Soft tissue repair devices, systems, and methods

ABSTRACT

Devices, systems and/or methods for repairing a lacerated tendon or ligament adjacent a repair site. In one embodiment, a repair device includes an elongated flexible structure and multiple anchors, the multiple anchors pre-positioned with the elongated flexible structure. The repair device may be coupled to the tendon or ligament at the repair site with a delivery device. The repair device may be pre-positioned in a cartridge such that the cartridge is loaded into the delivery device. The lacerated tendon or ligament is positioned within a cradle portion of the delivery device such that the tendon is positioned between the cradle portion and the cartridge that holds the repair device. The delivery device may then be triggered to actuate and drive the repair device from the cartridge to couple to the lacerated tendon or ligament. In this manner, the repair device may be anchored to the lacerated tendon.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit, and is acontinuation-in-part of, U.S. patent application Ser. No. 13/953,709,filed Jul. 29, 2013, which claims the benefit of U.S. Provisional PatentApplication No. 61/804,570, filed Mar. 22, 2013, and U.S. ProvisionalPatent Application No. 61/677,239, filed Jul. 30, 2012, the disclosuresof each are hereby incorporated by reference herein in their entirety.The present application also claims the benefit of U.S. ProvisionalPatent Application No. 62/053,056, filed Sep. 19, 2014, U.S. ProvisionalPatent Application No. 62/040,451, filed Aug. 22, 2014, U.S. ProvisionalPatent Application No. 62/007,783, filed Jun. 4, 2014, and U.S.Provisional Patent Application No. 61/952,114, filed Mar. 12, 2014, thedisclosures of each are hereby incorporated by reference herein in theirentirety.

TECHNICAL FIELD

The present invention relates generally to repairing a lacerated tendonor ligament. More particularly, the present invention relates todevices, systems, and methods for repairing tendon and/or ligaments at arepair site.

BACKGROUND

Lacerated flexor tendon repair, as an example, is a procedure performedtens-of-thousands of times a year in the United States alone. For alltypes of tendons in the human anatomy, early post-operative mobilizationis beneficial to restoring maximal tendon function following injury andrepair. Adhesion formation is a common complication following tendonrepair, but can be reduced through motion rehabilitation programs assoon as possible following a surgery. By preventing adhesion formationand gliding resistance, tendon healing may be enhanced. However, thefailure rate of tendon repairs is close to 30 percent, primarily becauseof overloading at the repair site. Although an objective of tendonrepair is to provide adequate strength for passive and active motionduring rehabilitation, it is important to maintain a delicate balancebetween rehabilitative motion protocols and fatiguing the repair site.

Typical procedures for lacerated tendon repair use one or more suturesto mend the two ends of a tendon together using complex suture patterns.While this can provide a good initial repair, the strength and qualityof the repair may quickly degrade with subsequent loading andmobilization. Although postoperative therapy may be utilized to reduceadhesion, the resulting tension can induce gap formation or tendonrupture at the repair site, seriously impairing the outcome of therepair. Gapping at the repair site has many negative effects, such asreduced repair strength, tendon rupture, and an increased probabilityfor adhesion.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to various devices,systems and methods for repairing a tendon or ligament in a body. Forexample, in one embodiment, a medical device system configured to fuse afirst tendon end to a second tendon end of a lacerated tendon isprovided. The medical device system including a delivery device and arepair device. The delivery device including a body, a handle extendingfrom the body, a trigger associated with the handle, an elongated guide,a cartridge, and a slider member. The elongated guide is operativelycoupled to the body, the elongated guide defining a longitudinal guideaxis, and the elongated guide including a drive shaft and a pusher blockextending along the longitudinal guide axis. The cartridge is removablycoupled to an end of the elongated guide. The slider member is slidablycoupled to a distal portion of the elongated guide. The slider memberincludes a cradle portion such that the cradle portion is fixed to theslider member and positioned distal of the slider member. The cradleportion includes an elongated bed surface defining a longitudinal cradleaxis, the longitudinal cradle axis being substantially perpendicular tothe longitudinal guide axis, the bed surface of the cradle portionconfigured to receive a first tendon portion and a second tendon portionof the lacerated tendon. The repair device is configured to bepositioned within the cartridge. The repair device includes an elongatedflexible member and anchors configured to extend through the elongatedflexible member. Each of the anchors including a base with legsextending from the base from a proximal end to a distal free end suchthat the legs from the proximal end to the distal free end extendsubstantially parallel with the longitudinal guide axis and theelongated flexible member extends substantially perpendicular relativeto the longitudinal guide axis.

In one embodiment, upon the lacerated tendon being positioned in thecradle portion, the trigger is actuated to compress the anchors throughthe lacerated tendon to couple the elongated flexible member to thelacerated tendon. In another embodiment, upon actuation of the trigger,the drive shaft moves distally to push the anchors through the cartridgeso that the legs extend through the first and second tendon portions, tothen compress against the bed surface so that the legs curl back into adistal side of the first and second tendon portions with the base ofeach of the anchors coupling the elongated flexible member to a proximalside of the first and second tendon portions. In another embodiment, thebed surface of the cradle portion comprises anvil channels definedtherein, the anvil channels sized and configured to receive end portionsof the legs of the multiple anchors to curl the end portions and bundleportions of the lacerated tendon.

In another embodiment, the elongated guide includes a spring positionedwithin the elongated guide and coupled to the slider member, the springconfigured to bias the cradle portion toward the cartridge. In a furtherembodiment, the elongated guide includes a locking mechanism associatedwith the slider member, the locking mechanism configured to prevent theslider member from movement along the elongated guide.

In still another embodiment, the multiple anchors include a u-shapedconfiguration. In another embodiment, the elongated flexible memberincludes a lattice structure. In yet another embodiment, the elongatedflexible member includes one or more polymeric filaments. In a furtherembodiment, the one or more polymeric filaments extend with at least oneof a weaved, braided, and knitted configuration. In another embodiment,the multiple anchors are separate and discrete from each other such thatthe multiple anchors are positioned along a length of the elongatedflexible member in at least one of a staggered arrangement and analigned arrangement.

In another embodiment, the multiple anchors extend from the elongatedflexible member along a first portion and a second portion of theelongated flexible member, the elongated flexible member including anintermediate portion extending between the first portion and the secondportion of the elongated flexible member. In a further embodiment, uponthe lacerated tendon being coupled to the elongated flexible member, thefirst and second portions of the elongated flexible member areconfigured to elongate as a force is placed upon the tendon and theintermediate portion of the elongated flexible member is configured tosubstantially resist elongation of the tendon.

In another embodiment, the delivery device further includes a flexiblecable configured to be operatively coupled between the handle and theelongated guide, the flexible cable configured to facilitate remotetriggering of the handle relative to the elongated guide. In a furtherembodiment, the flexible cable is configured to operatively provide aforce to the pusher block, the pusher block configured to push theanchors from the cartridge. In another embodiment, the flexible cable isremovably coupled to at least one of the elongated guide and the handle.In another embodiment, the delivery device further includes a drivingmechanism for driving the anchors from the cartridge, the drivingmechanism including at least one of the drive shaft, a cable, ahydraulic mechanism, a pneumatic mechanism, and an electro-mechanicalmechanism.

In accordance with another embodiment of the present invention, a repairdevice configured to fuse first and second ends of a tendon or ligamenttogether is provided. The repair device includes an elongated flatflexible member and multiple anchors. The elongated flat flexible memberincludes a first portion and a second portion with an intermediateportion between the first and second portions, the first and secondportions configured to elongate and the intermediate portion configuredto substantially resist elongation, the first and second ends of thetendon or ligament configured to be abutted against each other andpositioned adjacent the intermediate portion and first and second endportions of the tendon or ligament are configured to be positionedadjacent and along the respective first and second portions of theelongated flat flexible member. The multiple anchors each having a basewith legs extending from the base, the legs of each of the anchorsextending from or alongside the elongated flat flexible member. Themultiple anchors are configured to couple the first end portion and thesecond end portion of the tendon or ligament to the respective first andsecond portions of the elongated flat flexible member such that thefirst and second ends of the tendon or ligament are fixedly abutted toeach other along the intermediate portion of the elongated flat flexiblemember. With this arrangement, upon the tendon or ligament being coupledto the elongated flat flexible member, the elongated flat flexiblemember is configured to elongate along a length of the respective firstportion and the second portion of the elongated flat flexible member asthe first and second end portions of the tendon or ligament elongate,and wherein the intermediate portion substantially resists elongation soas to maintain a substantially fixed position so that the first andsecond tendon ends fuse together.

In one embodiment, the elongated flat flexible member includes a latticestructure. In a further embodiment, the lattice structure at theintermediate portion extends at a first angle relative to a longitudinalaxis of the elongated flat flexible member and the lattice structure atthe first and second portions extends at a second angle relative to thelongitudinal axis of the elongated flat flexible member, the first anglebeing smaller than the second angle. In another further embodiment, thelattice structure includes at least one of one or more polymericfilaments and metallic struts.

In another embodiment, the elongated flat flexible member includes oneor more polymeric filaments. In a further embodiment, the one or morepolymeric filaments extend with at least one of a weaved, braided, andknitted configuration.

In another embodiment, the multiple anchors are separate and discretefrom each other, the multiple anchors positioned along a length of theelongated flat flexible member in at least one of a staggeredarrangement and an aligned arrangement. In still another embodiment,each of the multiple anchors include a u-shaped configuration. Inanother embodiment, the at least one of the multiple anchors and theelongated flat flexible member include a bioresorbable material. In yetanother embodiment, the elongated flat flexible member includes amonolithic super elastic material.

In another embodiment, the elongated flat flexible member includesmultiple pad portions with one or more flexible members extendingbetween each of the multiple pad portions, at least the multiple padportions of the first and second portions of the elongated flat flexiblemember are configured to align and couple to at least one of themultiple anchors.

In accordance with another embodiment of the present invention, a methodfor repairing a lacerated tendon or ligament having a first end and asecond end is provided. The method includes: providing a delivery devicehaving a drive shaft defining a drive shaft axis and a removablecartridge positioned distal the drive shaft, the cartridge holding anelongated flat flexible member with multiple anchors coupled to theelongated flat flexible member; positioning a first end portion and asecond end portion of the tendon or ligament within an elongated bedsurface of a cradle of the delivery device with the first and secondends of the tendon or ligament abutted against each other, the elongatedbed surface defining a cradle axis such that the cradle axis isperpendicular to the drive shaft axis; and coupling the elongated flatflexible member with the multiple anchors to the first end portion andthe second end portion within the cradle by actuating a trigger of thedelivery device so as to actuate the drive shaft distally to effectmovement of the anchors and the elongated flat flexible member from thecartridge, through the first and second end portions of the tendon orligament, and to then compress the anchors against the bed surface ofthe cradle so that the anchors curl back into the tendon or ligament.

In one embodiment, the method step of positioning includes positioningthe first end portion and the second end portion of the tendon orligament within the cradle so that free ends of legs of the multipleanchors are positioned adjacent the first and second end portions of thetendon or ligament, the legs extending within the cartridgesubstantially parallel with the drive shaft axis and extendingsubstantially perpendicular with the cradle axis. In another embodiment,the method step of coupling includes compressing the multiple anchorsthrough the first tendon portion and the second tendon portion such thatend portions of legs of each of the multiple anchors curl and bundleportions of the tendon or ligament. In another embodiment, the methodstep of providing includes providing the elongated flat flexible memberhaving a lattice structure such that the multiple anchors are coupled tothe lattice structure.

In another embodiment, the method step of providing includes providingthe elongated flat flexible member with an elongated length defining afirst portion and a second portion with an intermediate portiontherebetween, the first and second portions being configured to elongatealong the elongated length and the intermediate portion being configuredto substantially resist elongation. In a further embodiment, the methodstep of coupling includes coupling the elongated flat flexible member tothe first and second end portions of the tendon or ligament so that thefirst and second portions of the elongated flat flexible member elongatealong the elongated length thereof as the tendon or ligament elongateswith the intermediate portion substantially resisting elongation so thatthe first and second ends of the tendon or ligament fuse together.

In a further embodiment, the method step of providing includes providingthe elongated flat flexible member with a lattice structure defining alongitudinal axis defined along the elongated length of the elongatedflat flexible member, the lattice structure at the intermediate portionextends at a first angle relative to a longitudinal axis of theelongated flat flexible member and the lattice structure at the firstand second portions extends at a second angle relative to thelongitudinal axis of the elongated flat flexible member, the first anglebeing smaller than the second angle. In another embodiment, the methodstep of providing includes providing the elongated flexible memberhaving at least one of one or more polymeric filaments and a metallicstructure.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other advantages of the invention will become apparentupon reading the following detailed description and upon reference tothe drawings in which:

FIG. 1 is a perspective view of an elongated flat member having alattice structure, according to an embodiment of the present invention;

FIG. 2 is a perspective view of the elongated flat member, depicting theflat member positioned within a lacerated tendon with a tool forinserting staples, according to one embodiment of the present invention;

FIG. 2A is a cross-sectional view taken along section 2A of FIG. 2,depicting a staple positioned in the tendon with the flat member,according to another embodiment of the present invention;

FIG. 3 is a cross-sectional view of the tendon and flat member of FIG.2, depicting another embodiment of a staple, according to anotherembodiment of the present invention;

FIG. 4 is a top view of another embodiment of an elongated flat member,according to the present invention;

FIG. 5 is a cross-sectional view of the flat member of FIG. 4 positionedin a tendon and secured with staples, according to another embodiment ofthe present invention;

FIG. 6 is a top view of another embodiment of an elongated flat member,depicting a mid-portion of the flat member having a different structurethan other portions thereof, according to the present invention;

FIG. 7 is a top view of another embodiment of an elongated flat member,depicting the flat member having multiple pads with flexible memberstherebetween, according to the present invention;

FIG. 7A is a cross-sectional view taken along section 7A of FIG. 7,depicting the flexible members having a flat structure, according toanother embodiment of the present invention;

FIG. 8 is a cross-sectional view of the flat member of FIG. 7 positionedwithin a tendon and secured with staples at one of the pads, accordingto another embodiment of the present invention;

FIG. 9 is a top view of another embodiment of the an elongated flatmember, depicting the flat member having multiple pads with a latticestructure and flexible members therebetween, according to the presentinvention;

FIG. 10 is a perspective view of an elongated member, depicting theelongated member over a lacerated tendon, according to anotherembodiment of the present invention;

FIG. 11 is a cross-sectional view of the tubular member of FIG. 10,depicting the elongated member surrounding the tendon, according toanother embodiment of the present invention;

FIG. 12 is a top view of a repair device, depicting the repair device ascut from a flat sheet, according to another embodiment of the presentinvention;

FIG. 13 is an end view of the repair device of FIG. 12, depicting therepair device in a constrained state with a tendon positioned therein,according to another embodiment of the present invention;

FIG. 14 is an end view of the repair device of FIG. 12, depicting therepair device in a non-constrained state with a tendon positionedtherein, according to another embodiment of the present invention;

FIG. 15 is a perspective view of a cradle as a portion of a tool,according to one embodiment of the present invention;

FIG. 16 is a perspective view of the cradle, depicting a laceratedtendon positioned therein, according to another embodiment of thepresent invention;

FIG. 17 is a perspective view of the tool with the cradle and an anchorguide, depicting the tool with a lacerated tendon therein, according toanother embodiment of the present invention;

FIG. 18 is a side view of the tool with a tendon therein, depicting aninsert guide positioned against the tendon and adjacent one side of thetool, according to another embodiment of the present invention;

FIG. 19 is a side view of the tool with a tendon therein, depicting aflat member being deployed from the insert guide and within the tendon,according to another embodiment of the present invention;

FIG. 20 is a perspective view of a repair device, depicting the flatmember within the tendon and secured to the tendon and flat member,according to another embodiment of the present invention;

FIG. 21 is a perspective view of a tool system for accurate positioningof a repair device within a lacerated tendon, according to anotherembodiment of the present invention;

FIG. 22 is an end view of a cradle portion of the tool system, accordingto another embodiment of the present invention;

FIGS. 23-28 are perspective views of the tool system of FIG. 21,depicting method steps for employing the tool system, according toanother embodiment of the present invention;

FIG. 29 is a perspective view of a repaired lacerated tendon with arepair device positioned within the tendon, according to anotherembodiment of the present invention;

FIG. 30 is a perspective view of another embodiment of a tool system foraccurate positioning of a repair device within a lacerated tendon,according to the present invention;

FIG. 31 is a front view of a cradle portion, depicting a window definedin the cradle portion through which the tendon is exposed for horizontalincision of the tendon, according to another embodiment of the presentinvention;

FIG. 32 is a top view of a flat member positioned within a severedtendon, according to another embodiment of the present invention;

FIG. 33 is a cross-sectional view of the flat member of FIG. 32,depicting a staple or anchor securing the flat member to a tendon,according to the present invention;

FIG. 34 is an enlarged front view of a portion of a flat member,depicting the flat member having crimps and/or folds, according toanother embodiment of the present invention;

FIG. 35 is a perspective view of a repair device, according to anotherembodiment of the present invention;

FIG. 36 is a perspective view of another embodiment of a repair devicehaving an elongated flat member with multiple anchors, according to thepresent invention;

FIG. 37A is an end view of the repair device, depicting the multipleanchors in a first position, according to another embodiment of thepresent invention;

FIG. 37B is an end view of the repair device, depicting the multipleanchors in a second position, according to another embodiment of thepresent invention;

FIG. 38 is a perspective view of a delivery device, depicting thedelivery device with a cartridge holding a repair device, according toanother embodiment of the present invention;

FIG. 39 is an enlarged perspective view of an elongated guide and slidermember of the delivery device, according to another embodiment of thepresent invention;

FIG. 40 is a partial cross-sectional side view of the delivery device,according to another embodiment of the present invention;

FIG. 41 is an enlarged cross-sectional view of the slider member and thecartridge, depicting a cradle portion in a first position and moveableto a second position, according to another embodiment of the presentinvention;

FIG. 42 is an enlarged cross-sectional view of the slider member andcartridge, depicting a drive shaft moved to an engaged position toanchor the repair device to a lacerated tendon, according to anotherembodiment of the present invention;

FIGS. 43A and 43B are end views of another embodiment of a repairdevice, depicting anchors of the repair device in the first anchorposition and the second anchor position, respectively, according to thepresent invention;

FIG. 44A and 44B are end views of another embodiment of a repair device,depicting anchors of the repair device in the first and second anchorpositions, respectively, according to the present invention;

FIG. 45 is a perspective view of another embodiment of a deliverysystem, according to the present invention;

FIG. 45A is a cross-sectional view taken along section A-A of FIG. 45 ofthe delivery system, according to another embodiment of the presentinvention;

FIG. 46 is a perspective view of the cross-section of FIG. 45A of thedelivery system, according to another embodiment of the presentinvention;

FIG. 47 is an end view of an anchor guide of a cartridge, according toanother embodiment of the present invention;

FIG. 48 is an end view of another embodiment of a medical device,according to another embodiment of the present invention;

FIG. 49 is a perspective view of another embodiment of a medical devicesystem, depicting a flexible housing for remote actuation of the medicaldevice, according to another embodiment of the present invention; and

FIG. 50 is a simplistic cross-sectional view of a cartridge and drivingmechanism, according to another embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Various embodiments are disclosed herein of a soft tissue repair device.Such repair device may be sized and configured to approximate and fuse,for example, a lacerated tendon. The various embodiments may providestructure that maintains two ends of a lacerated tendon in an abuttingrelationship, without gapping, while allowing the tendon adjacent thetendon ends and along the length of the repair device to providecontrolled elongation of the tendon. In this manner, the repair deviceof the present invention may provide the proper healing required forfusing the tendon ends while still providing movement of the tendon tominimize atrophy and potential adhesions.

Referring to FIGS. 1, 2, and 2A, one embodiment of a repair device 20for tendon or ligament repair is depicted. With respect to FIG. 1, therepair device 20 may include an elongated flat member 22 that exhibits alattice structure 24. The elongated flat member may define alongitudinal axis 26 and extend with a longitudinal length 28 and awidth 30, which dimensions may provide a generally rectangular shape.Further, such elongated flat member 22 may include a planar or flatconfiguration that defines a depth 32 (see FIG. 2A).

The lattice structure 24 of the elongated flat member 22 may be amonolithic structure. In one embodiment, the flat member 22 may be ashape memory alloy or a polymeric material. In another embodiment, theelongated flat member 22 may exhibit flexible structuralcharacteristics. In another embodiment, the flat member 22 may be abioresorbable or bioabsorbable material. In another embodiment, the flatmember 22 may be laser cut, for example, from a flat sheet of Nitinol orany other suitable material, such as stainless steel, titanium,combinations thereof, or any other suitable biocompatible material, suchas a polymeric material.

The lattice structure 24 may include interconnected struts 34 thatdefine a multi-cellular structure. Such multi-cellular structure orstruts define cells 36 or openings extending through the depth 32 of theflat member 22. The struts 34 may be sized and configured uniformly overthe length 28 of the flat member 22. In this manner, the cells 36 andstruts 34 may be sized similarly over the length 28 of the flat member22. In another embodiment, the struts 34 may include variations alongthe length of the flat member 22. Such variations may include taperingalong the struts 34. The struts 34 that may be tapered provide strutportions that are more flexible at, for example, the taper than otherportions along the strut. In another embodiment, the struts 34 mayinclude angled or arcuate variations along particular struts 34 in theflat member 22 relative to other struts in the flat member. In otherwords, the struts 34 defining a given cell 36 may extend at angles (orwith an arcuate radius) different from the struts 34 defining anothercell of the lattice structure 24 to manipulate the behavior of the flatmember 22 over various portions of the flat member 22 upon a load beingplaced thereon. In this manner, the variations within the struts 34 maybe sized and configured to facilitate the elongated flat member 22 tostretch or elongate upon an axial load being placed upon the flat member22 via the tendon becoming loaded. Further, such variations in thestruts may facilitate elongation along the length 28 over particularregions. For example, the struts 34 in a middle portion 40 of the flatmember 22 may be sized and configured to minimize or substantiallyresist elongation of the flat member 22 over the middle portion 40.Further, the struts 34 along a first portion 42 and a second portion 44may be configured to facilitate elongation of the flat member 22 in theaxial direction along the first portion 42 and the second portion 44 ofthe flat member 22. In this manner, the struts 34 and cells 36 over themiddle portion 40 may be sized differently than the struts 34 and cells36 in the first and second portions 42, 44 along the length 28 of theflat member 22.

As depicted in FIGS. 2 and 2A, the elongated flat member 22 may bepositioned within a first tendon portion 7 and a second tendon portion 9of a lacerated tendon 5 such that first and second tendon ends 11, 13are abutted against each other. The flat member 22 may be positioned bysimply inserting about half of the flat member 22 into the first tendonportion 7 and then inserting the other half within the second tendonportion 9. The flat member 22 may be centered and axially aligned withthe lacerated tendon 5. Once the flat member 22 is positioned, the flatmember 22 may be secured to the lacerated tendon 5 with multiple staples50 extending through the tendon 5 and the flat member 22.

The staples 50 may be introduced, for example, with a needle instrument60. The needle instrument 60 may include a tubular introducer 62 with apointed tip 64. The staples 50 may be consecutively aligned within alumen of the tubular introducer 62 and may be deployed therefrom with apusher member (not shown). The staples 50 may be formed of a shapememory alloy or polymeric material and may be moveable from a firstposition to a second position. The first position may be a constrainedstate and may exhibit a straight, elongated configuration, similar to astraight wire. The staple 50 may extend between a first end 52 and asecond end 54, each end having a sharpened point or barb or the like.The second position may be a non-constrained state or relaxed state andmay be in the form of a c-shape or the like. The staple may beself-expandable from the first position to the second position.

FIG. 2 depicts various stages for introducing the staples 50 through theflat member 22. For example, the needle introducer 60 with its pointedtip 64 may be positioned over, for example, the second tendon portion 9and pushed into the tendon and through a cell 36 of the flat member 22to the opposite side of the second tendon portion 9. At this stage, asdepicted to the left of the inserted needle instrument 60, the tubularintroducer 62 may be withdrawn while maintaining the position of thepusher member such that the staple 50 may be deployed and left extendingthrough the flat member 22. The staple 50 is depicted in the firstposition or constrained position (straight position) as the staple wouldbe positioned within the needle instrument 60. However, as the staple 50is deployed, the staple may automatically self-expand from the firstposition to the second position, as depicted in its c-shapedconfiguration, depicted to the left of the staple 50 in its straightposition and also shown in FIG. 2A. In this manner, multiple staples 50may be positioned through the cells of the flat member 22 along thelength 28 of the flat member 22. Such staples 50 may be positioned alongthe length 28 in a staggered arrangement, a linear arrangement, orthrough particular portions along the length, such as at the middleportion 40 and the first and second portions 42, 44 of the flat member22.

With reference again to FIGS. 2 and 2A, the staple 50 is depicted in thenon-constrained position or c-shaped position. In this position, thestaple 50 may be engaged with the tendon 5 and engaged with the flatmember 22. The staple 50 may include a mid-section 56 and oppositelyextending curved portions 58 to provide, for example, the c-shapedconfiguration. The mid-section 56 may be configured to extend through acell 36 and the depth 32 of the flat member 22 while the curved portions58 may be exposed at opposite sides of the tendon 5. Further, the curvedportions 58 may extend back into the tendon 5 with the barb or pointextending inward and engaged with the tendon 5.

As set forth, the staples 50 of this embodiment may be made from a shapememory material configured to self-expand from the first constrainedposition to the second non-constrained position. As such, the staples 50may be formed of a super elastic material, such as a shape memory metalor a polymer. The metal or alloy may be Nitinol or any other alloy thatincludes shape memory characteristics. The staples 50 may be heat-setinto the c-shaped configuration employing heat setting techniques asknown to one of ordinary skill in the art. In the case of a polymermaterial, it is contemplated to use a bioresorbable material orbioabsorbable material or any other general bio-compatible polymer forboth the flat member 22 and the staples 50, or even a shape-memorypolymer.

Referring to FIG. 3, another embodiment of one or more staples 70 thatmay be employed with the flat member 22 is provided. In this embodiment,the staple 70 may be u-shaped. The staple may include a mid-section 72or base and a first extension 74 and a second extension 76. Themid-section 72, upon inserting the staple 70 through the tendon 5 andthe flat member 22, may be exposed on one side of the tendon 5. Thefirst and second extensions 74, 76 may extend through two differentopenings or cells 36 defined in the flat member 22 or lattice structureand extend to an opposite side of the tendon 5. At the opposite side ofthe tendon 5, the first and second extensions 74, 76 may be bent towardeach other and be exposed on the opposite side of the tendon 5. Suchextensions of the staples 70 may bend toward each other utilizing astaple tool (not shown) sized and configured for employing the staples70 of this embodiment to secure the tendon 5 to the flat member 22. Inthis embodiment, the staple 70 may be formed of a metallic material or apolymeric material. The metallic material may be stainless steel,titanium, or any other suitable biocompatible metallic material, such asbioresorbable materials, which may include a magnesium material or thelike. The polymeric material may be any suitable polymeric material,such as a bioresorbable or bioabsorbable polymeric materials or anyother suitable polymeric material, as known in the art.

Now with reference to FIGS. 4 and 5, another embodiment of a repairdevice 80 including a flat member 82 that may include flexiblestructural characteristics and that may be secured to, for example, atendon 5 or ligament with staples 90 or anchors is provided. In thisembodiment, the flat member 82 may include similar structural featuresas the previous embodiment. The flat member 80 may include a latticestructure 84 or the like. The lattice structure 84 may include one ormore filaments 86, the one or more filaments intertwined together in atleast one of a weaved, knitted, and a braided arrangement orconfiguration. The one or more filaments 86 may be a fibrous polymericmaterial or a cotton fibrous material or combinations thereof. Thefilaments may also be formed from various metallic materials, such as asuper elastic material, such as Nitinol. In one embodiment, the latticestructure 84 formed of filaments 86 may include a covering 88 such thatthe lattice structure 84 may be encapsulated with a polymeric materialor, in another embodiment, the lattice structure 84 may be sandwiched orreinforced between two thin films or sheets of polymeric material, suchas silicon and, for example, heat pressed together.

The flat member 82 may be inserted within the tendon 5 or ligament in asimilar manner as the previous embodiment. Upon inserting the flatmember 82 within a lacerated tendon 5, the staples 90 may be placedthrough a mid-portion 92 of the flat member 82 and through first andsecond portions 94, 96 of the flat member 82. For example, one or morestaples 90 may be placed in the mid-portion 92 to stabilize the tendonends relative to the mid-portion 92 of the flat member 82. Further, oneor more staples 90 may be placed, for example, through a first endportion 98 and a second end portion 99 of the respective first andsecond portions 94, 96 of the flat member 82. With this arrangement, theflat member 82 may elongate between the staples 90 positioned throughthe first end portion 98 and the mid-portion 92 of the flat member 82 asa load is placed upon the tendon 5 Likewise, the flat member 82 mayelongate between the staples 90 positioned through the second endportion 99 and the mid-portion 92 of the flat member 82 as the load isplaced on the tendon 5. As shown in FIG. 5, the staples 90 may include au-shaped configuration and include similar structural characteristics asthat set forth relative to FIG. 3. In another embodiment, the staples 90employed with the flat member 82 of FIG. 4 may be self-expandablestaples similar to that depicted in FIG. 2A.

With reference to FIG. 6, another embodiment of a repair device 100including a flat member 102 that may be elongated and that may includeflexible structural characteristics is provided. This embodiment may besimilar to the previous embodiment, except the lattice structure 104itself may include variations along a length 106 of the flat member 102.As in the previous embodiment, the flat member 102 may include one ormore filaments 108 that may also include a covering 109 of reinforcedsilicon or the like, the filaments 108 intertwined together in a weaved,knitted, and/or a braided arrangement. In this embodiment, the weave,knit, and/or braided arrangement may be tighter, denser, thicker, orinclude additional strands over, for example, a mid-portion 110 of theflat member 102 relative to the first portion 112 and the second portion114 of the flat member 102. Otherwise said, the first and secondportions 112, 114 of the flat member 102 may include looser, less dense,or less strands along the length of the flat member in comparison tothat provided in the mid-portion 110 of the flat member 102. In anotherembodiment, the durometer of the strands may be harder or stiffer overthe mid-portion 110 of the flat member 102 as compared to the durometerof the strands or filaments 108 extending over the first and secondportions 112, 114 of the flat member 102. In another embodiment, thediameter or thickness of the strands or filaments 108 may be larger overthe mid-portion 110 as compared to the diameter of the strands orfilaments 108 extending over the first and second portions 112, 114 ofthe flat member 102.

Similar to the previous embodiment, one or more staples 90 (similar tothat shown in FIG. 5) may be inserted through the flat member 102 at themid-portion 110 as well as over the first and second portions 112, 114of the flat member 102. Further, similar to the previous embodiment,such one or more staples 90 may be positioned at the first end portion116 and the second end portion 118 so that the flat member 102 mayelongate along its length between the inserted staples 90 at theirrelative first and second portions 112, 114 of the flat member 102 as aload in placed upon the tendon while maintaining the lacerated first andsecond tendon ends 11, 13 fixed and abutted together.

Now with refer to FIGS. 7, 7A, and 8, another embodiment of a repairdevice 120 including a flat member 122 sized and configured to beinserted within lacerated ends of a tendon 5 and stapled thereto isprovided. In this embodiment, the flat member 122 may include flexiblestructural characteristics. The flat member 122 of this embodiment maybe sized and configured to elongate via flexible members 124 therealongso that the flat member 122 may elongate with defined distances overparticular portions of the flat member 122 with a mid-portion 126configured to be rigid, without elongation or with minimized elongation.

In one embodiment, the flat member 122 may include multiple pads 125sized and configured to receive one or more staples 148 or anchors. Themultiple pads 125 may be aligned to form an elongate flat member 122 andmay include one or more flexible members 124 therebetween. Each of thepads 125 and flexible members 124 may exhibit a monolithic flatstructure having a substantially common thickness or depth 128. Further,the flat member 122 may include a mid-pad 130, a first pad 132, a secondpad 134, a third pad 136, and a fourth pad 138, each with the one ormore flexible members 124 extending between respective pads 125. Forexample, the mid-pad 130 may be positioned between the first pad 132 andthe second pad 134. The first pad 132 may be positioned between thethird pad 136 and the mid-pad 130. Similarly, the second pad 134 may bepositioned between the mid-pad 130 and the fourth pad 138.

The mid-pad 130 may include one or more flexible members 124 extendingfrom opposite sides thereof to the respective first pad 132 and thesecond pad 134. Such one or more flexible members 124 extending from themid-pad 130 may include a first flexible configuration 140. The firstpad 132 may also include one or more flexible members 124 extendingtherefrom to the third pad 136, which may include a second flexibleconfiguration 142 Likewise, the second pad 134 may include one or moreflexible members 124 extending therefrom to the fourth pad 138, whichone or more flexible members 124 may include the second flexibleconfiguration 142. With this arrangement, the second flexibleconfiguration 142 may flex and elongate to a greater degree than thefirst flexible configuration 140.

Each of the pads 125 may be sized and configured to receive one or morestaples 148 or anchors. For example, the mid-pad 130 may receive twostaples 148 while the other pads may receive a single staple 148, butalso may be configured to receive additional staples. In anotherembodiment, the mid-pad 130 may not receive any staples 148. Each of thepads 125 may be a rigid flat portion with openings 144 defined thereinthat may be sized and configured to receive the staples 148, except themid-pad 130 may not receive the staples 148. The rigid flat portions mayinclude a square or rectangular shape, the corners of which may berounded.

In one embodiment, the flat member 122, similar to the previousembodiments, may be inserted or positioned within lacerated ends of atendon 5 or ligament with the first and second tendon ends 11, 13positioned over the mid-pad 130 and abutted against each other. One ormore staples 148 may be inserted through the tendon 5 and the mid-pad130 adjacent the first and second tendon ends 11, 13 while also ensuringthat the tendon ends 11, 13 maintain an abutted relationship. One ormore staples 148 may then be inserted through, for example, the tendon 5and through the first pad 132 Likewise, one or more staples 148 may beinserted in a similar manner through each of the second pad 134, thethird pad 136 and the fourth pad 138. Upon a load being placed on thetendon 5, subsequent to the surgery, the flexible members 124 mayelongate and flex between the pads 125 while the mid-pad 130 issubstantially rigid to maintain the abutted tendon ends 11, 13 againsteach other to facilitate proper fusion of the lacerated tendon 5.Further, the flexible members 124 having the first flexibleconfiguration 140, adjacent the mid-pad 130, provide minimal elongationto ensure the tendon ends 11, 13 have minimal load placed thereon. Theflexible members 124 having the second flexible configuration 142 may beconfigured to elongate further then the first flexible configuration140, thereby, allowing for the tendon 5 to elongate there along as aload is placed on the tendon 5. Such elongation of the flat member 122over particular portions thereof facilitates greater healing efficiencyin the lacerated tendon 5 as the tendon may still be used and receiveloads placed thereon while maintaining the tendon ends 11, 13 abuttedagainst each other.

Similar to the previous embodiments, the flat member 122 of thisembodiment includes a first portion 150 and a second portion 152 withthe mid-portion 126 therebetween. The first portion 150 and the secondportion 152 may elongate while the mid-portion 126 is substantiallyrigid to substantially resist elongation. However, as set forth above,the first and second portions 150, 152 of this embodiment includesflexible members 124 having the first and second flexible configurations140, 142 with different elongation structural characteristics. Thus, theelongation characteristics of the flat member 122 become greater fromthe mid-portion 126 toward opposite first and second ends 154, 156 ofthe flat member 122.

In another embodiment, the flat member 122 may be minimized in thenumber of pads 125 employed. For example, the flat member 122 mayinclude the mid-pad 130 positioned between the first pad 132 and thesecond pad 134 such that the first and second pads 132, 134 may be theopposite ends of the flat member 122. The flexible members 124 extendingfrom the mid-pad 130 to the respective first and second pads 132, 134may include a similar or common flexible configuration such that suchflexible configuration for each of the flexible members 124 may elongatea similar distance. In this manner, the lacerated tendon ends 11, 13 maybe fixed to the mid-pad 130 for proper fusion while the remainingportions of the flat member 122 may facilitate controlled elongation ofthe tendon 5 to minimize the load placed on the tendon ends 11, 13 whilestill allowing the tendon 5 to become stressed and exercised to effectproper healing of the tendon.

With reference now to FIG. 9, another embodiment of a repair device 160including a flat member 162, similar to the embodiment of FIG. 7, isprovided. In this embodiment, the pads 164 may each include a latticestructure 166 defining openings 168 therethrough. Such lattice structure166 may be sized and configured to provide structural rigidity in thepads 164 while also providing openings 168 therethrough to readily beable to insert staples (not shown) for attaching to the tendon 5. Inother words, having the lattice structure 166 may limit error uponsecuring the flat member 162 to the tendon 5 as anyone of the openings168 defined in a particular pad 164 may receive a staple.

As in the previous embodiment, the flat member 162 may include one ormore flexible members 170 with a first flexible configuration 172 and asecond flexible configuration 174, the second flexible configuration 174configured to elongate (with more flexibility) than the first flexibleconfiguration 172. As such, the first flexible configuration 172 of theone or more flexible members 170 may extend from opposite sides of themid-pad 176 to the respective first pad 178 and second pad 180.Similarly, the second flexible configuration 174 of the one or moreflexible members 170 may extend from the first pad 178 and the secondpad 180 to the third pad 182 and the fourth pad 184, respectively. Inanother embodiment, the mid-pad 176 may include a solid, rigid structure(but for openings to receive the staples) similar to the mid-pad shownin FIG. 7, with the remaining first pad 178, second pad 180, third pad182, and fourth pad 184 exhibiting the lattice structure 166.

The embodiments of the flat member 122, 162 depicted in FIGS. 7 through9 may be formed from any suitable biocompatible material, such as ametallic or polymeric material. For example, the flat member may belaser cut from a flat sheet of shape memory material or super-elasticmaterial, such as Nitinol or the like, with the staples made from shapememory material or stainless steel or any other biocompatible metallicmaterial, similar to other described anchors/staples described herein.In another embodiment, the flat member 122, 162 and staples may also beformed from a polymeric material, such as a bioresorbable material, orany other suitable polymeric material.

With reference to FIGS. 10 and 11, another embodiment of a repair device200 is provided. In this embodiment, the repair device 200 may be atubular member 202 and sized and configured to be positioned around theoutside of a lacerated tendon 5. The tubular member 202 may be formedwith multiple filaments 204 weaved and/or braided together in a tubularconfiguration. Similar to previous embodiments, the tubular member 202may include a mid-portion 206 and first and second portions 208, 210.The mid-portion 206 of the tubular member 202 may be stiffer, mayinclude additional filaments 204, or the filaments may include a greaterdiameter than the first and second portions 208, 210 of the tubularmember 202. As in previous embodiments, the mid portion 206 of therepair device 200 may be configured to be positioned over and adjacentto the first and second tendon ends. Once the repair device 200 isproperly positioned over the lacerated tendon 5, staples 212 may beinserted through the tubular member 202 and through the tendon 5 at themid portion 206 of the tubular member 202. Additional staples 212 may beinserted along the first and second portions 208, 210 of the repairdevice 200, such as adjacent first and second ends of the tubular member200. With this arrangement, the mid-portion 206 of the tubular member202 maintains the first and second tendon ends abutted against eachother while the first and second portions 208, 210 of the repair device200 may elongate along a longitudinal length 214 thereof as a load isplaced upon the tendon 5. The repair device 200 of this embodiment maybe formed of a metallic material, such as a shape memory alloy. Inanother embodiment, the repair device 200 may be formed from a polymericmaterial, such as a bioresorbable material, or any suitable polymericmaterial. As in previous embodiments, the staples may be formed of ametallic or polymeric material. In one embodiment, the staples may bemetallic or polymeric bioresorbable materials.

With reference to FIGS. 12-14, another embodiment of a repair device 220is provided. In this embodiment, the repair device 220 may wrap around alacerated tendon 5. FIG. 12 depicts the repair device 220 as cut from aflat sheet, such as a flat sheet of Nitinol. FIG. 13 depicts an end viewof the repair device 220 in a constrained position, being constrained byan applicator (not shown). FIG. 14 depicts an end view of the repairdevice 220 in a non-constrained position with the applicator removedsuch that the repair device 220 automatically wraps around the tendon 5.

With respect to FIGS. 12-14, the repair device 220 of this embodimentmay include a base portion 222 that extends along a longitudinal length224 of the device. The base portion 222 may include a first portion 226and a second portion 228 with a mid-portion 230 therebetween. Further,the base portion 226 may include tines 232 extending from a surface ofthe base portion 222 along the longitudinal length 224 thereof such thatthe tines 232 extend inward toward the mid-portion 230 from both thefirst and second portions 226, 228 of the base portion 222. The firstand second portions 226, 228 may also include multiple laterallyextending extensions 234, each extending from opposite lateral sides ofthe base portion 222. The repair device 220 may be heat-set in theconfiguration depicted in FIG. 14 so that the repair device 220 can bemoved to the first constrained position (shown in FIG. 13) with anapplicator (not shown) and, upon the applicator being removed, therepair device 220 may automatically move to the heat-set configurationor wrapped configuration.

The repair device 220 may be implanted by first holding the device inthe first constrained position, as depicted in FIG. 13. In thisposition, the lacerated tendon 5 may be placed within an upper open endof the repair device 220 with first and second tendon ends positionedover the mid-portion 230 of the device in an abutted arrangement. Oncethe lacerated tendon 5 is properly positioned over the base portion 222of the device, the applicator (not shown) may be removed to allow themid-portion 230 and extensions 234 to wrap over the lacerated tendon 5and close-off its upper open end. The tendon 5 may maintain its positionrelative to the device via the tines 232 and the extensions 234 over thetendon. The extensions 234 may also include tines extending therefrom tomaintain the tendon 5 in its proper position.

Now referring to FIGS. 15 through 20, a tool 240 for inserting andsecuring any one of the flat members, set forth in FIGS. 1, 4, 6, 7, and8, to a lacerated tendon 5 is provided. With respect to FIG. 15, thetool 240 may include a cradle 242. The cradle may include an interiorsurface 244 and an exterior surface 246. The cradle 242 may be elongatedwith a length 248 to define a cradle axis and may extend along thelength with a u-shaped lateral cross-section. The cradle 242 may includetines 250 extending upward along the length 248 from the interiorsurface 244. Such tines 250 may be linearly aligned along the length 248and may be centrally aligned along the length 248. Further, the tines250 may extend substantially perpendicular relative to a bottom of theinterior surface 244. In another embodiment, the tines 250 may be angledtoward a mid-point 254 of the interior surface. Furthermore, theinterior surface 244 may define multiple grooves 252 (or otherwisereferred to as recesses or channels) defined therein. Such grooves 252may be sized and configured to receive and engage with staples (notshown) so as to act as an anvil bucket, discussed in more detailhereafter.

As shown in FIG. 16, the cradle 242 may be sized and configured toreceive a lacerated tendon 5 or ligament. The first and second tendonends 11, 13 of the lacerated tendon 5 may be positioned over themid-point 254 of the cradle 242 such that the interior surface 244 ofthe cradle 242 substantially surrounds a portion of the lacerated tendon5. Further, the tendon 5 may be positioned in the cradle 242 such thatthe tines 250 (FIG. 15) may maintain the tendon 5 in its position withinthe cradle 242. With respect to FIG. 17, upon the tendon 5 beingpositioned within the cradle 242, a staple guide 260 or cover may thenbe positioned over the cradle 242 to enclose and engage an upper side ofthe cradle 242. The staple guide 260 may be elongated and include a flatconfiguration with a similar length of the cradle 242 and may be sizedto fit snug over the tendon 5 in a fixed manner, via notches,protrusions, and/or grooves along the cradle 242 and sides of the stapleguide 260. The staple guide 260 may be employed to assist in managingthe position of the tendon 5 in the cradle 242. Such staple guide 260may include slots 262 defined therein that extend laterally relative tothe length 248 of the cradle 242. Such slots 262 may be sized andconfigured to receive staples (not shown) therethrough. The slots 262may be spaced from each other and may correspond with the grooves 252(FIG. 15) defined in the cradle 242. The staple guide 260 may alsoinclude tines 264 (see FIG. 19) configured to extend downward into thetendon 5 so as to stabilize and position the tendon 5 relative to thecradle 242.

With respect to FIGS. 18-19, upon the lacerated tendon 5 or ligamentbeing placed within the cradle 242 and the staple guide 260 beingpositioned thereover, the lacerated tendon 5 may then be ready toreceive a flat member 270 (depicted with dashed line). Such may beemployed with an insert guide 272. The insert guide 272 may be a flattubular member sized and configured to receive the flat member 270 (suchas any one of the flat members discussed in the previous embodiments)within a lumen defined longitudinally through the insert guide 272. Theinsert guide 272 may also act in cooperation with a pusher member (notshown) disposed within the lumen of the insert guide 272 and that may besized and configured to effectively push the flat member 270 from theinsert guide 272. The insert guide 272 may include a leading end 274 ordistal end that may be sharp to initiate an incision in the tendon 5 sothat the tendon may receive the insert guide 272 and/or the flat member270 between the cradle 242 and the staple guide 260. As depicted, theinsert guide 272 may be inserted into the tendon 5 between the cradleand the staple guide.

In one embodiment, the insert guide 272 may be inserted into the tendon5 just slightly between the cradle 242 and the staple guide 260 andadjacent a first end 276 of the tool 240. At this position, the pushermember (not shown), disposed within the insert guide 272 and behind(proximal) the flat member 270, may push the flat member 270 forward ordistally from the insert guide 272 and within the tendon 5 and tool 240.The tines 250, 264 extending from the staple guide 260 and the cradle242 may act as a guide in funneling or assisting the flat member 270 tobe properly positioned and aligned within the tendon 5. Upon the flatmember 270 being positioned within the tendon 5, the insert guide 272may be removed from adjacent the first end 276 of the tool 240.

In another embodiment, the insert guide 272 may be inserted into thetendon 5 and funneled through the tendon 5 and tool 240 between thetines 250, 264 so that the sharp leading end 274 may be positionedadjacent a second end 278 of the tool 240. The flat member 270 may alsobe positioned within the insert guide 272 and adjacent the leading end274 with the pusher member (not shown) positioned proximal the flatmember 270. The insert guide 272 may then be moved proximally orwithdrawn with the pusher member holding the position of the flat member270 within the tendon 5. In this manner, the flat member 270 may bedeployed from the insert guide 272 and positioned within the tendon 5and the tool 240.

With reference to FIGS. 19 and 20, once the flat member 270 ispositioned within the tendon 5 and within the tool 240 with the insertguide 272 removed, staples 280 may then be pushed through the slots 262defined in the staple guide 260 via a staple tool (not shown), similarto the staple tool described relative to FIGS. 38-42 (not shown). Suchstaples 280 may be configured to extend through the tendon 5 and theflat member 270, similar to that described in previous embodiments. Oncethe staples 280 are positioned, the staple guide 260 and the cradle 242may be removed from the tendon 5, leaving the lacerated tendon 5 withthe flat member 270 within the tendon 5 and secured with the staples280. As depicted, the flat member 270 may be similar to the flat member22 described relative to FIG. 1. However, as set forth, the flat member270 employed with the tool 240 may be any one of the flat membersdiscussed herein.

In another embodiment, the tool 240 discussed above may be employed withthe tubular member 202, as depicted in FIG. 10. As can be appreciated,such tubular member 202 may be positioned over a lacerated tendon 5 andthen placed in the cradle 242 with the staple guide 260 positionedthereover, similar to that depicted in FIG. 17. Staples may then beinserted through the staple guide 260 and through the tubular member 202and tendon 5.

The various components of the tool 240 may be formed from metallicmaterials or polymeric materials, or combinations thereof, and may bemade using typical machining, laser cutting, or various moldingtechniques, or any other known manufacturing techniques as known to oneof ordinary skill in the art.

Referring to FIG. 21, another embodiment of a tool system 300 forinserting and securing a flat member 301 (which may be any one of theflat members set forth in the embodiments herein) to a lacerated tendon5 is provided. The tool system 300 may include a spring clamp 302 and aguided scalpel 304. Such spring clamp 302 and guided scalpel 304 may beemployed as tools for accurately affixing the lacerated tendon 5together.

The spring clamp 302 may include a clamp handle 306 with an upper handleportion 308 and a lower handle portion 310. The spring clamp 302 mayalso include a cradle portion 312 and a clamp portion 314 each of whichmay be in the form of extensions of the upper and lower handle portions308, 310, respectively. For example, the clamp portion 314 may include atongue 316 extending from the lower handle portion 310 such that thetongue 316 extends through an opening 318 defined in a downwardextension 320 extending from the upper handle portion 308 and over thecradle portion 312. The tongue 316 may include multiple windows 322 orslits defined in an end portion 324 of the tongue 316, the windows 322positioned over the cradle portion 312 and sized and configured toreceive anchors or staples (not shown) therethrough.

With respect to FIGS. 21 and 22, the cradle portion 312 may bepositioned to define a portion of the opening 318 defined in thedownward extension 320. The cradle portion 312 may be positioned andsecured to a platform portion 326 extending horizontally from thedownward extension 320. The cradle portion 312 may include a tendonchannel 328 defined therein sized and configured to receive and positionthe severed tendons 5 there along. The cradle portion 312 may alsoinclude guide channels 330 defined in or along opposite outer sides ofthe cradle portion 312, the guide channels 330 extending parallel withthe tendon channel 328. The tendon channel 328 may include a surfacealong its bottom surface that may include two or three secondary grooves329 defined in the bottom surface. The secondary grooves 329 extendingco-axial and along at least a portion of a length of the tendon channel328 and sized and configured to act as an anvil to engage the anchors orstaples (not shown).

The spring clamp 302 includes a spring element such that the upper andlower handle portions 308, 310 may be biased outward to facilitate thetongue 316 to be biased against an upper side of the cradle portion 312.In other words, the tongue 316 and cradle portion 312 are biasedtogether such that an underside surface of the tongue 316 may be biasedagainst and may be in direct contact with an upper side of the cradleportion 312. With this arrangement, a physician may grasp the springclamp 302 at the clamp handle 306 and squeeze the upper and lower handleportions 308, 310 toward each other to separate the tongue 316 from thecradle portion 312. Likewise, the physician may loosen the grip of thespring clamp 302, which in turn automatically moves the tongue 316against the cradle portion 316 via the spring element.

With respect to FIGS. 21 and 23, as set forth, the tool system 300 mayinclude the guided scalpel 304. The guided scalpel 304 may include anelongated handle 332, one or more blades, and guide rods 334. Theelongated handle 332 may define a handle axis 333 along its longitudinallength extending between opposite first and second ends 335, 337. In oneembodiment, the handle 332 may include a first blade 336 and a secondblade 338 fixedly extending from opposite ends of the elongated handle332. The first and second blades 336, 338 may include a generally flatstructure and elongated with an end portion having a beveled edge 340extending to a cutting edge 342. The guide rods 334 may extend alongeach side of the first and second blades 336, 338, extending in aparallel arrangement such that each of the first and second blades 336,338 extends between a pair of guide rods 334. The guide rods 334 may becylindrically shaped and sized and configured to correspond with theguide channels 330 defined in the cradle portion 312. Also, the guiderods 334 may extend from the handle 332 relative to the first and secondblades 336, 338 along the same plane or extend in generally parallelplanes. For example, the plane of a given pair of guide rods 334 may bedefined between and by longitudinal axes 344 of the given pair of guiderods 334. The plane of the first or second blades 336, 338 may bedefined along a central blade axis 346 such that the plane extendsgenerally centrally and symmetrically relative its elongated flatstructure and extend parallel or co-planar with the plane defined by thecorresponding guide rods 334. In one embodiment, the blade axis 346 maybe substantially co-axial with the handle axis 333. In anotherembodiment, the blade axis 346 may be parallel with the handle axis 333.The purpose and function of the first and second blades 336, 338extending in separate or parallel planes relative to the plane of theirassociated guide rods 334 will be described in detail hereafter.

Referring now to FIGS. 21, and 23 through 29, a method for employing thetool system 300 with a flat member 301 upon a severed tendon 5 will nowbe described. With respect to FIGS. 21 and 23, a first tendon portion 7may be placed within the tendon channel 328 of the cradle portion 312 bysqueezing the clamp handle 306 to open the clamp portion 314. The firsttendon portion 7 may be positioned within the cradle portion 312 so thata first tendon end 11 aligns with a first edge 348 of the tongue 316and, once positioned, the clamp portion 314 may be released so that thetongue 316 biases tight against the first tendon portion 7 within thecradle portion 312.

At this juncture, a thickness or diameter of the first tendon portion 7may be determined. Once the thickness is determined, the guided scalpel304 may be employed at one of four orientations. For example, if thefirst tendon portion is approximately three millimeters thick frombottom to top as it sits in the cradle portion 312, then the physicianmay orient the guided scalpel 304 with, for example, the numeral threeindicia on the handle 332 to be positioned and aligned adjacent thefirst tendon portion 7, as depicted in FIG. 23. With this particularorientation, a distance between the plane of the first blade 336 and theplane of the associated guide rods 334 may be separated by, for example,1.5 mm so that the first blade 336 will correspond with a center axis350 of the first tendon portion 7. Similarly, if the first tendonportion 7 is, for example, 4 mm thick, than a physician may orient theguided scalpel 304 with the numeral four indicia on the handle 332 to bepositioned and aligned adjacent the first tendon portion 7. Thisparticular orientation may provide a distance between the plane of thesecond blade 338 and the plane of its associated guide rods 334 of 2 mmso that the blade may accurately correspond with the center axis 350 ofthe first tendon portion 7. Likewise, turning the handle 332 over maydisplay the numeral one and two indicia on the handle to provide otherpredetermined distances between the plane of the first and second blades336, 338 and the plane of their associated guide rods 334.

Once the guided scalpel 304 is properly oriented to correspond with agiven thickness of the first tendon portion 7, the guide rods 334 may beinserted within the guide channels 330 of the cradle portion 312. Forexample, with respect to FIG. 24, the guided scalpel 304 may be movedwith the guide rods 334 inserted through and into the guide channels 330to a hard stop, which may be defined by the first end 335 of the handle332. In this manner, the first blade 336 may provide an accurateincision through the center axis 350 of the first tendon portion 7. Theguided scalpel 304 may then be withdrawn from the first tendon portion7.

With respect to FIGS. 24 and 25, the flat member 301 may be insertedinto the incision made by the first blade 336 in the first tendonportion 7. In one embodiment, the flat member 301 may include a sutureand needle arrangement at each end of the flat member 301. The needlemay be threaded through the incision of the first tendon portion 7 andthen laterally through a side of the first tendon portion 7 to then pullthe flat member 301 into the incision so that about half of the flatmember 301 is positioned in the first tendon portion 7 and about half ofthe flat member 301 is exposed at the first tendon end 11, as depictedin FIG. 25. Once the flat member 301 is appropriately positioned withinthe first tendon portion 7, the portion of the flat member 301 withinthe tendon may be anchored to the tendon. Such anchoring may be employedwith an anchor instrument (not shown) such that anchors may be insertedthrough the windows 322 defined in the tongue 316 to pass through theflat member 301 and the first tendon portion 7. As in previousembodiments, the anchors may pass through bottom and top sides of thefirst tendon portion 7 as well as through cells or openings defined inthe flat member 301, similar to that depicted with internally positionedflat members and anchors in previous embodiments to thereby anchor theflat member 301 to the first tendon portion 7.

In another embodiment, prior to inserting and anchoring the flat member301, the first tendon portion 7 may be removed from the cradle portion312 so that the physician may thread the flat member 301 via the sutureand needle within the incision in the first tendon portion 7 without theaid of the tendon being clamped in the cradle portion 312. Once the flatmember 301 is properly positioned in the first tendon portion 7, thefirst tendon portion 7 may be repositioned and aligned in the cradleportion 312 so that the flat member 301 may be anchored to the tendonwith, for example, anchors or staples.

As depicted in FIG. 26, once the first tendon portion 7 has beenanchored to the flat member 301, the first tendon portion 7 may beremoved from the cradle portion 312. The second tendon portion 9 maythen be positioned in the cradle portion 312 so that a second tendon end13 is aligned with a second edge 352 of the tongue 316 and then clampedtherein with the tongue 316 biased over the second tendon portion 9.Similar to that set forth previously, the guided scalpel 304 may then bepositioned to provide an incision along the center axis 350 of thesecond tendon portion 9 by sliding the guide rods 334 through the guidechannels 330 until reaching the hard stop at the first end 335 of thehandle 332, as depicted in FIG. 27. Once the incision is made within thesecond tendon portion 9, the guided scalpel 304 may be removed. Thesecond tendon portion 9 may then be threaded with the suture and needleat the end of the exposed portion of the flat member 301 at the firsttendon portion 7 into the incision to pull the exposed portion of theflat member 301 into the incision and into the second tendon portion 9,thereby, abutting the first tendon end 11 against the second tendon end13, as depicted in FIG. 28. At this juncture, the second tendon portion9 may be anchored to the flat member 301 positioned within the secondtendon portion 9 by inserting anchors (not shown) through the windows322 of the tongue 316, similar to that previously set forth. Once theflat member 301 is anchored to the first and second tendon portions 7,9, the lacerated tendon 5 may be removed from the cradle portion 314 ofthe spring clamp 302, as depicted in FIG. 29. The suture and needles maythen be snipped and removed from the repaired tendon 5 with the flatmember 301 positioned therein.

With respect to FIG. 30, another embodiment of a tool system 360 withsimilar features of the tool system 300 previously described relative toFIGS. 21-29, except this tool system 360 may be employed by slicinghorizontally through first and second portions 7, 9 of a severed tendon5 for accurately positioning a flat member 362 within the severed tendon5. It should be noted that the flat member 362 employed with the toolsystem 360 may be any one of the flat member embodiments or the like setforth herein. In one embodiment, the tool system 360 may include atendon holder 364, an inserter member 366, and a scalpel 368.

For example, with respect to FIGS. 30 and 31, the tendon holder 364 mayinclude a handle 370 coupled to a cradle portion 372. The cradle portion372 may be sized and configured to receive end portions of a severedtendon 5 therein with a anchor guide (not shown) positioned over thesevered tendon 5 with a sandwiching arrangement. The cradle portion 372and anchor guide of this embodiment may include similar structuralfeatures for receiving and containing the severed tendon and thenreceiving anchors or staples, similar to that described relative to thecradle 242 and staple guide 260 in FIGS. 15-17.

The cradle portion 372 of the embodiment depicted in FIGS. 30 and 31 mayalso include guide rails 374 with a window 376 defined in a side wall378 of the cradle portion. Such window 376 may be elongated, extendingbetween a first end 380 and a second end 382, and defined between theguide rails 374, the guide rails 374 extending laterally from the sidewall 378 of the cradle portion 372 and extending longitudinally alongthe side wall 378 of the cradle portion 372.

The inserter member 366 may include an elongated handle portion 384 witha pair of arms 386 extending from one end of the elongated handleportion 384. The arms 386 may be sized and configured to grasp a repairdevice, such as the flat member 362. In one embodiment, the arms 386 mayinclude an actuating element 388 that may move the arms 386 between anoutward open position and an inward closed position. In the inwardclosed position, the arms 386 may be biased toward an inward position,as shown by arrows 390, to be biased toward each other such that eacharm 386 may hold the flat member 362 at opposite ends thereof. In theoutward open position, the arms 386 may be moved outwardly by theactuating element 388 being moved, as shown by arrow 392, to release theflat member 362 from the arms 386.

The tool system 360 of this embodiment may be employed with a severedtendon 5 by first positioning first and second tendon portions 7, 9 ofthe severed tendon 5 in the cradle portion 372. With the severed tendon5 positioned within the cradle portion 372, the anchor guide may then bepositioned over the cradle portion 372, similar to that depicted in FIG.17, as previously set forth. The tendon 5 may then receive a horizontalslice 394 extending through both the first and second tendon portionswith the scalpel.

The scalpel 368 may include a blade 396 extending from a scalpel handle397. The scalpel handle 397 may include an end portion 398 with opposingsides sized and configured to fit between the guide rails 374. Theopposing sides may each include a surface 402 that extends to anabutting edge 404, the surface 402 and blade 396 defining a length 406that corresponds to a predetermined depth through the window 376 definedin the cradle portion 372 for making an incision within the tendon 5. Assuch, the scalpel 368 may be inserted through the window 376 adjacentthe first end 380 of the window 376 until each abutting edge 404 abutsthe guide rail 374 with the opposing sides positioned between the guiderails 374. In this manner, the scalpel 368 may be inserted into a sideof the tendon 5 at an accurate predetermined distance. The scalpel 368may then be moved from the first end 380 of the window 376 to the secondend 382 of the window 376 defined in the cradle portion 372, thereby,providing a slice 394 extending horizontally along a length of the firstand second portions 7, 9 of the severed tendon 5. The scalpel 368 maythen be removed.

At this stage, the inserter member 366, holding the flat member 362therewith, may then be oriented and aligned with the previously madeslice 394 through the window 376. The inserter member 366 may then bemoved forward so that the flat member 362 is inserted through the window376 and into the sliced incision in the tendon 5. The inserter member366 may then be moved to the outward open position via the actuatingelement 388 to release the flat member 362 within the incision in thetendon 5, after which, the inserter member 366 may be withdrawn. Withthe flat member 362 positioned within the tendon 5, anchors may then beinserted through the slots defined in the anchor or staple guide (seeFIG. 17), to thereby fix the flat member 362 to the tendon 5 and thus,affix the first and second tendon ends 11, 13 together.

As set forth, although the flat members 301, 362 depicted with the toolsystems 300, 360 herein are similar to the flat member embodimentdescribed in FIG. 1, such flat members 301, 362 may be similar to theembodiments described in FIGS. 4, 6, 7, and 9, or variations thereof.Such variations of a flat member may include a weaved, knitted, orbraided polymer fiber or wire, similar to that shown in FIGS. 4 and 6,but without being disposed with the covering 88 between thin polymersheets or embedded within a thin polymer material. In this manner, otherembodiments of a flat member may include all the structuralcharacteristics of the weaved, knitted, and/or braided polymer fiber orwire described relative to the lattice structures of FIGS. 4 and 6, butfor the polymeric encasing.

In addition, relative to FIGS. 32 and 33, an embodiment of a flat member410, without the polymeric encasing, may include a lattice or meshstructure having flexible structural characteristics. In one embodiment,the lattice or mesh structure may include a weaved, knitted, and/orbraided configuration. Further, in one embodiment, the lattice may bemade from polymeric filaments 411 or fibers that are weaved, knitted,and/or braided to form a ribbon or the flat member 410. The flat member410 may include a length 412 extending between first and second ends414, 416 and define an axis 418 extending longitudinally and centrallythrough the flat member 410. The flat member 410 may also include awidth 420 and a depth 422.

The flat member 410 of this embodiment may include first and secondportions 424, 426 with an intermediate portion 428 therebetween, similarto previous embodiments. The first and second portions 424, 426 of theflat member 410 may provide structural characteristics that elongate orfacilitate strain elongation along the length 412 or axis 418 of theflat member 410 and, specifically, along the first and second portions424. As in previous embodiments, the intermediate portion 428 mayprovide structural characteristics that substantially prevent or resistelongation along the length 412 of the intermediate portion 428. In oneembodiment, the term substantially prevents or resists elongation maymean minimal elongation (between, for example, adjacent anchors 430closest to the ends of the tendon 5 at the laceration or at theintermediate portion) in the order of up to about 0.2 mm, including zeroor no elongation. In another embodiment, minimal elongation may mean upto about 0.5 mm along the intermediate portion. In this manner, minimalelongation may occur as a load is placed upon the tendon and may comeback or un-elongate back to zero or no elongation or remain up to about0.2 mm. Such definition of minimal elongation for an intermediateportion of an elongated flat flexible member may be consistent with anyone of the embodiments described herein setting forth an intermediateportion that substantially resists elongation along a length of theintermediate portion.

At the intermediate portion 428, the angle of the filaments 411 mayextend with a smaller pitch or smaller angle relative to the axis 418than the filaments 411 along the first and second portions 424, 426 ofthe flat member 410. Otherwise said, the pitch or angle of the filaments411 along the first and second portions 424, 426 may be larger than thepitch or angle of the filaments 411 along the intermediate portion 428.Such angle or pitch may facilitate the structural characteristics ofelongation of the first and second portions 424, 426 and substantiallyprevent elongation along the intermediate portion 428. With thisarrangement, the flat member 410 may be inserted internally within asevered tendon 5 and anchored to the tendon 5, utilizing anchors 430 orthe like or any other anchors for fixing the flat member 410 to thetendon 5. In one embodiment, such anchors 430 may be discrete andseparate relative to the frame member. Further, the flat member 410 ofthis embodiment may be inserted into the tendon 5 employing any one ofthe tool systems described herein.

Upon affixing the flat member 410 within the tendon 5, as the tendon 5elongates with a load, the first and second portions 424, 426 may alsoelongate with the tendon 5. Further, as the tendon elongates, theintermediate portion 428 being positioned adjacent the severed ends ofthe tendon may also substantially prevent elongation to, thereby,facilitate the severed ends to properly heal and allow the otherportions of the tendon adjacent or over the first and second portions424, 426 to be stressed or exercised and become stronger.

In another embodiment, depicted in FIG. 34, a side view along a portionof the length of the flat member 410 of FIG. 32 is shown. With respectto FIGS. 32 and 34, in one embodiment, the flat member 410 may includecrimps 432 or folds that extend laterally along the width 420 or acrossthe length 412 of the flat member 410. Such folds or crimps 432 may beplaced along the length 412 at predetermined positions at, for example,positions along the first and second portions 421, 426 of the flatmember 410. The crimps 432 may be made by heating the polymericfilaments 411 to the crimped or folded position or any other techniqueknown in the art. In another embodiment, the filaments 411 may includeone or more loops along their length so that upon a force being placedalong the length of the flat member, the length may elongate at leastalong the first and second portions 424, 426. In another embodiment, thefilaments 411 may extend with a zig-zag along the length of thefilaments. In this manner, upon the flat member 410 being secured to asevered tendon 5, the first and second portions 424, 426 may furtherelongate along their respective lengths as the tendon 5 is tensioned andelongates while maintaining the severed portions substantially affixedadjacent each other along the intermediate portion 428 of the flatmember 410.

With respect to FIG. 35, another embodiment of a repair device 440 forrepairing a severed tendon is provided. In this embodiment, the repairdevice 440 may include one or more lines 442 and multiple anchors 444 orstaples. The one or more lines 442 may be formed of multiple filamentsand/or fibers that may be braided, weaved, and/or knitted, or the like.The one or more lines 442 may be coupled to the anchors 444. Suchcoupling may be employed with posts and/or eyelets (not shown) viawrapping the line 442 around or through the respective posts and/oreyelets. In another embodiment, the anchors 444 may include bends orrecesses (not shown) that may receive the lines 442 for wrapping andcoupling to the anchors 444. The one or more lines 442 may be coupled toopposite ends 445 of a top end 446 of each of the anchors 444. Inanother embodiment, the one or more lines 442 may be coupled to amid-portion 448 or base at, or adjacent to, the top end 46 of each ofthe anchors 444. Further, in another embodiment, the one or more lines442 may be coupled to the opposite ends 445 and the mid-portion 448 ofthe top end 446 of the anchors 444. Such one or more lines 442 mayinclude multiple folds, crimps, loops, and/or zig-zags along first andsecond portions 450, 452 of the repair device 440 without such folds,crimps, loops, and/or zig-zags along an intermediate portion 454 of therepair device 440. The repair device 440 may be secured to a severedtendon 5 such that the anchors 444 may extend through first and secondend portions 7, 9 of the severed tendon 5 and the one or more lines 442remain on the outer surface of the severed tendon 5. In anotherembodiment, another repair device, substantially identical to the repairdevice, may be positioned and secured to an opposite side of the severedtendon. In this manner, the two repair devices 440 may be secured to asevered tendon, each repair device 440 on opposite sides of the tendon5.

In another embodiment, the one or more lines may extend between adjacentstaples at an angle, extending with a braided, weaved, and/or knittedconfiguration. In another embodiment, the one or more lines may be inthe form of a ribbon or flat member, similar to that shown in FIG. 32,that may or may not include pre-attached anchors.

The anchors or staples, as set forth herein, may be a metallic materialor a polymeric material. Such metallic materials may be stainless steel,Nitinol, titanium, or magnesium, or combinations thereof or any othersuitable biocompatible metallic material or bioresorbable materials, orthe like. The polymeric materials may be any suitable polymericmaterial, such as a bioresorbable or bioabsorbable polymeric materialsor any other suitable biocompatible polymeric material. The repairdevice, as set forth herein, may be any suitable biocompatible material,such as a metallic or polymeric material. The repair device may alsoinclude a bioresorbable material or components of the repair device thatare bioresorbable.

In one embodiment, the repair device may include collagen attachedthereto. The collagen may be coated, layered, inserted, and/orimpregnated into the repair device. In one embodiment, the collagen maybe formed on the filaments or fibers of the repair device in a manner toenhance and accelerate the healing of the tendon at the repair site.Such collagen may be added to any one of the repair devices disclosedherein.

The components of the tool systems 300, 360 may be made of metallicand/or polymeric materials and manufactured using machining, lasercutting, crimping, and/or various molding techniques, as known to one ofordinary skill in the art. For example, the spring clamp may be ametallic material with portions of the handle made of a polymericmaterial. The cradle portion may also be made of a polymeric material bymolding or machining the cradle portion and then fixing the cradleportion to the downward extension using typical fastening techniques.The handle portion of the guided scalpel may be formed of a suitablepolymeric material with the blades made of a metallic material. Theguide rods may be a metallic or a polymeric material.

Now with reference to FIG. 36, another embodiment of a repair device 500for repairing a lacerated tendon or the like is provided. Thisembodiment may include similar features to the embodiment depicted anddescribed in FIG. 35. In this embodiment, the repair device may exhibitan elongated flexible member 502 with multiple anchors 504 extendingthrough the elongated flexible member 502. The elongated flexible member502 may include a length 506, a width 508 and a depth 510, the length506 defining a longitudinal axis 512. The elongated flexible member 502may include and extend between a first end 514 and a second end 516, thefirst end 514 being opposite the second end 516. Further, the flexiblemember 502 may include an upper surface 518 and an under-side surface520 and define a rectangular shaped periphery. Further, the elongatedflexible member 502 may include a first portion 522 and a second portion524 with an intermediate portion 526 therebetween. The first portion 522may include a first series of the multiple anchors 504 and the secondportion 524 may include a second series of the multiple anchors 504.

The flexible member 502 may include a ribbon like structure. Such ribbonlike structure may be flexible such that it may be readily foldable orbendable and may readily move over or around a small radius. In oneembodiment, the flexible member 502 may be somewhat rigid when placed intension. In another embodiment, the flexible member 502 may exhibit aflat structure. In still another embodiment, the flexible member 502 maybe formed with multiple filaments 528. The multiple filaments 528 may beinterconnected such that the filaments may be braided, knitted, and/orwoven together to form a flat structure. In one embodiment, the multiplefilaments 528 may be polymeric filaments that are biocompatible. Inanother embodiment, such polymeric filaments may be bioresorbable orbioabsorbable.

The first and second ends 514, 516 of the flexible member 502 mayinclude folded portions such that ends of flexible member 502 may befolded over to the under-side surface 520 to define the first and secondends 514, 516. Such folded portions may reinforce the ends of theflexible member 502. In another embodiment, the ends may be reinforcedwith stitching or an adhesive or other polymeric layer or any othercomponent to reinforce the first and second ends so that unraveling ofthe multiple filaments 528 is prevented.

As in previous embodiments, upon a load being placed along the axis 512of the flexible member 502, the structural characteristics of theflexible member 502 may be such that the first portion 522 and thesecond portion 524 of the flexible member 502 may be configured toelongate while the intermediate portion 526 may be configured to limitor substantially resist elongation. In one embodiment, the multiplefilaments 528 may be interconnected in a manner (i.e., weaved, braided,and/or knitted) so as to facilitate elongation and to limit elongationover predetermined portions of the length 506 of the flexible member502. In one embodiment, the multiple filaments 528 along the first andsecond portions 522, 524 may extend with a first pitch 530 or anglerelative to the axis 512 of the flexible member 502 and the multiplefilaments 528 along the intermediate portion 526 may extend with asecond pitch 532 or angle relative to the axis 512 of the flexiblemember 502 such that the first pitch 530 is greater than the secondpitch 532. In another embodiment, the multiple filaments 528 may includea similar pitch along the length of the flexible member, but includedifferent patterns of weaving, braiding, and/or knitting along thelength 506 to facilitate elongation and minimize elongation of theflexible member 502. In still another embodiment, the multiple filaments528 of the flexible member 502 may exhibit a substantially continuous orconstant pitch and/or a continuous or constant weave, braided, orknitted pattern between the interconnected filaments 528 along thelength 506 of the flexible member 502 such that elongation of theflexible member 502 is limited or such that the elongation of flexiblemember 502 may be substantially constant along the length 506 of theflexible member 502.

As set forth, the elongated flexible member 502 may include multipleanchors 504. Such multiple anchors 504 may be pre-attached orpre-inserted through the flexible member 502 prior to anchoring therepair device 500 to a lacerated tendon. In one embodiment, the multipleanchors 504 may be positioned and pre-inserted through the first andsecond portions 522, 524 of the flexible member 502 in a staggeredarrangement, as depicted. In another embodiment, the multiple anchors504 may be positioned and pre-inserted through the flexible member 502such that the multiple anchors 504 are aligned along the length 506 ofthe first and second portions 522, 524 of the flexible member 502.

The multiple anchors 504 may be formed of a metallic or polymericmaterial or combinations thereof. Further, the multiple anchors 504 maybe formed of a biocompatible material or a bioresorbable orbioabsorbable material. For example, the multiple anchors 504 may beformed of stainless steel, titanium, Nitinol, or magnesium, orcombinations thereof, or any other suitable material, known in the art.

With respect to FIGS. 37A and 37B, end views of the multiple anchors 504positioned in the flexible member 502 are provided. The multiple anchors504 may be moved from a first anchor position or linear position (FIG.37A) to a second anchor position or curved position (FIG. 37B). Asdepicted in FIG. 37A, in the first anchor position, each anchor 504 mayinclude a u-shaped configuration. The first anchor position may be apre-use position or the position prior to the anchors 504 being anchoredto a tendon. Such u-shaped configuration may include an intermediateportion 536 or base and first and second legs 538, 540, the first andsecond legs extending substantially perpendicular from and relative tothe intermediate portion 536. Each of the anchors 504 may be positionedand inserted through apertures defined by the multiple filaments 528 ofthe flexible member 502. Further, as set forth, such anchors 504 may bepre-inserted or pre-attached to the flexible member 502 prior toemploying the repair device 500 with a lacerated tendon. For example,upon being inserted through the flexible member 502, the intermediateportion 536 may extend substantially parallel with the upper surface 518or outer surface of the flexible member 502. Further, each of the firstand second legs 538, 540 may include barbs 542 that may be canted towardthe intermediate portion 536. With this arrangement, the barbs 542 maybe configured to facilitate ready insertion of the anchors 504 throughthe flexible member 502 and deter migration of the anchors 504 from theflexible member 502 in the opposite direction.

Further, such barbs 542 may be positioned adjacent a distal end of thefirst and second legs 538, 540 such that the flexible member 502 may bepositioned above or slightly proximal of the barbs 542, as depicted inFIG. 37A. Such flexible member 502 may be moveable along the first andsecond legs 538, 540 of the anchors 504, as indicated by arrow 543. Forexample, upon the anchors 504 being in the first anchor position, theflexible member 502 may be in a first flexible member position, asdepicted in FIG. 37A, the flexible member 502 being adjacent to andslightly proximal the canted tines or barbs 542. Upon the anchors 504being moved to the second anchor position, the flexible member 502 maysimultaneously move along the first and second legs 538, 540, as shownby arrow 543 in FIG. 37A, to a second flexible member position. In thesecond flexible member position, the flexible member 502 may bepositioned to abut the intermediate portion or upper portion 536 of theanchors 504, as depicted in FIG. 37B. Such flexible member 502 in thefirst flexible member position may assist in holding the anchors 504 inan aligned and straightened arrangement relative to each other upon therepair device 500 being positioned within a cartridge (not shown),discussed in further detail herein.

Further, in another embodiment, each of the first and second legs 538,540 can include an end with a point 544. The point 544 may extend anddefine an angled edge 546 or bevel such that the end portion of each ofthe legs are cut at an angle. For example, the angled edge 546 at theend of the first leg 538 may be cut in a common direction andorientation relative to the angled edge 546 of the second leg 540. Theangled edge 546 or bevel of the legs may be sized and configured tomanipulate the direction by which the legs bend to the second anchorposition. Further, as depicted in FIG. 37B, with the angled edge 546being in a common orientation or direction, the first and second legs538, 540 may bend in a common direction upon being driven into an anvilor within channels defined in a cradle portion (not shown). Further, thepoint 544 is configured to limit damage to the tendon 5 so as to bereadily inserted through the tendon 5.

With respect to FIGS. 36 and 37B, the anchors 504 may be positionedwithin the flexible member 502 in a staggered arrangement. Further, theanchors 504 may be positioned in the staggered arrangement such thateach leg of a given anchor 504 curls or bends in a first direction andan adjacently spaced anchor 504 with its legs bend in a seconddirection, the first direction being opposite the second direction. Inother words, the anchors 504 are staggered relative to each other andeach anchor 504 is oriented such that its associated legs bend inopposite directions relative to adjacent anchors 504 along the length506 of the flexible member 502. As such, the first and second legs 538,540 of a given anchor bend in a common direction or to a common lateralside with adjacently positioned anchors 504 oriented and bendingoppositely.

As set forth, the first and second legs 538, 540 of the multiple anchors504, upon moving to the second anchor position, move from a linearposition to a curled or bent position. In one embodiment, the legs aremoved to exhibit a curled portion 548. Such curled portion 548 may besized and configured to latch or grab a portion of the tendon 5 in abundled manner. Further, the curled portion of the legs include a radialcomponent 534 or radius sized to extend outside the tendon 5 at a lowerportion of the curled portion 548 and then extend back within the tendon5. The staggered arrangement of the multiple anchors 504 facilitates thecurled portions 548 of each anchor 504 to grab and bundle the tendon 5in a staggered manner relative to adjacent anchors 504.

Now with reference to FIGS. 38 and 39, a medical device system 550configured to fuse first and second tendon ends of a lacerated tendon isprovided. The medical device system 550 includes a delivery device 552or delivery gun and a repair device, such as the repair device 500 setforth in the previous embodiment.

In one embodiment, the delivery device 552 may include a body 554, ahandle 556, a trigger 558, and an elongated guide 560. The handle 556may extend downward from the body 554 with the trigger 558 associatedwith the handle 556. The trigger 558 may be a lever like structure orextension positioned adjacent the handle 556 so as allow a physician togrip the handle 556 and the trigger 558 to generate a force to theelongated guide 560. In this manner, the physician may manually actuatethe trigger 558, discussed further herein. One example of the body andhandle 556 with the trigger 558 that may be coupled to the elongatedguide 560 is described in U.S. Pat. No. 5,344,061, the disclosure ofwhich is hereby incorporated herein by reference in its entirety.

The elongated guide 560 may extend distally from the body 554 in abarrel like fashion. The elongated guide 560 may include a square orrectangular lateral cross-section. The elongated guide 560 may extendlongitudinally defining an axis 562 between a first end 564 and a secondend 566, the first end 564 coupled to the body 554. The second end 566or distal portion of the elongated guide 560 may include a cartridge 568and a slider member 570, the cartridge 568 removeably coupled to thesecond end 566 of the elongated guide 560.

With respect to FIGS. 39 and 41, the cartridge 568 may be sized andconfigured to slide and be inserted into a receiver portion 572 at thedistal portion of the elongated guide 560. In one embodiment, thereceiver portion 572 may be defined by upper and lower inner surfaces ofthe elongated guide 560 that include channels or grooves 574 or the likealong an inside surface of the distal portion of the elongated guide 560to facilitate structural outer surface components of the cartridge 568to be inserted and couple to the receiver portion 572, such as from alateral side of the elongated guide 560 or inserted at the distal end orsecond end 566 along the axis 562 of the elongated guide 560.

The cartridge 568 may be sized and configured to hold and position therepair device 500 therein. For example, the cartridge 568 may hold therepair device 500 within a hollow portion 576 defined therein such thatthe multiple anchors 504 of the repair device 500 may be positioned inthe first anchor position (fully extended and linear), as depicted inFIG. 37A. The cartridge 568 may include a first side 578 and a secondside 580, the first side 578 opposite the second side 580. The firstside 578 of the cartridge 568 may be a driving side configured to bedriven by a drive shaft 592. The second side 580 may be an engaging sidesuch that the multiple anchors 504 of the repair device 500 may engagethe tendon 5. For example, the second side 580 may exhibit or expose theends or points 544 of the multiple anchors 504 of the repair device 500such that the points 544 of the anchors 504 may extend distally orprotrude beyond the second side 580 of the cartridge 568. In thismanner, the points 544 of the anchors 504 may engage the tendon 5,discussed in further detail herein.

Further, the repair device 500 may be positioned in the cartridge 568such that the flexible member 502 may be positioned adjacent theintermediate portion or upper portion (not shown) of the anchors 504 (asdepicted in FIG. 41 or 48). In another embodiment, the flexible member502 may be disposed adjacent the second side 580 of the cartridge 568and adjacent the points 544 of the anchors (positioned similarly as thatdepicted in FIG. 37A). In another embodiment, the flexible member 502may be disposed at any intermediate position along the length of thelegs of the anchors 504. In any case, such flexible member 502 mayassist in stabilizing the anchors 504 within the cartridge 568 such thatthe anchors 504 maintain a generally perpendicular orientation relativeto the flexible member 502. In another embodiment, the cartridge 568 mayinclude a spring or clip (not shown) associated therewith to stabilizethe anchors 504 to maintain a generally perpendicular orientationrelative to the flexible member 502.

As set forth, the slider member 570 may be positioned over a distalportion of the elongated guide 560. The slider member 570 may include aslider portion 582 and a cradle portion 584, the cradle portion 584fixed to the slider portion 582 with an intermediate extension 586therebetween. Further, the cradle portion 584 may include a bed surface588 that may face the second side 580 of the cartridge 568. The bedsurface 588 may be elongated to define a longitudinal cradle axis, thebed surface 588 configured to receive tendon portions (not shown) withso that an axis of the tendon portions is substantially parallel withthe longitudinal cradle axis. Further, the longitudinal cradle axis or aplane of the bed surface maintains a fixed position to be substantiallyperpendicular relative to the axis 562 of the elongated guide 560.

The slider portion 582 may be slideably coupled to the elongated guide560, bi-linearly moveable or slidable along a portion of the length ofthe elongated guide 560. Further, a spring 590 may be disposed withinthe elongated guide 560 and coupled to the slider member 570 to bias theslider member 570 proximally and, more importantly, to bias the cradleportion 584 proximally. With this arrangement, the cradle portion 584may be moved between a first cradle position and a second cradleposition (shown in outline), as depicted with bi-directional arrow 597.The first cradle position may be an open position such that the cradleportion 584 and slider portion 582 are fully moved distally relative tothe elongated guide 560. The second cradle position may be a closed orengaged position such that the cradle portion 584 is moved proximallytoward and adjacent to the cartridge 568. In this manner, the cradleportion 584 of the delivery device 552 may be sized and configured toreceive first and second end portions of a lacerated tendon 5 along thebed surface 588.

In one embodiment, the slider member 570 may include a locking element594. The locking element 594 may be actuated between locked andun-locked positions. In the locked position, the locking element 594 mayprevent the slider member 570 from linearly moving along the elongatedguide 560. Similarly, in the un-locked position, the locking element 594may be actuated or loosened so as to facilitate the slider member 570 tomove proximally via the spring 590 or manually moved distally.

Referring now to FIGS. 40 through 42, the method for employing thedelivery device 552 to repair a lacerated tendon 5 or ligament will nowbe described. With respect to FIGS. 40 and 41, the cradle portion 584 ofthe slider member 570 is depicted in the first cradle position or theopen position. In this first cradle position, the cartridge 568 may beslid into and positioned within the distal portion of the elongatedguide 560, the cartridge 568 holding the repair device 500 therein. Withthe cartridge 568 properly positioned, first and second tendon portionsof the lacerated tendon 5 may be aligned over the bed surface 588 of thecradle portion 584, the tendon ends abutted against each other andcentered. To assist the physician in maintain the tendon portions withinthe cradle portion 584, the cradle portion 584 may include one or moreopenings or windows 640 (FIG. 45) extending through the bed surface 588or lateral sides 596 of the cradle portion 584. Such through holes orwindows may assist the physician to extend a needle or a suturetherethrough to hold and maintain the tendon portions in the cradleportion 584 or to facilitate increased viewability of the tendon ends.

Once the first and second tendon portions are positioned within thecradle portion 584, the cradle portion 584 may then be moved proximallyto the second cradle position (shown in outline form in FIG. 41) orengaged position, as shown by bi-directional arrow 597. Such may beemployed by actuating the locking element 594 to an unlocked position.The slider member 570 may then move proximally to the second cradleposition. In the second cradle position, the ends or points 544 of theanchors 504 exposed distally beyond the second side 580 of the cartridge568 are configured to engage the first and second end portions of thelacerated tendon 5 within the cradle portion 584. In this engaged orsecond cradle position, the tendon end portions may be stabilized andheld between the bed surface 588 of the cradle portion 584 and thepoints 544 of the anchors 504 extending from the cartridge 568 in asandwiched position.

In another embodiment, the second side 580 of the cartridge 568 mayinclude protrusions or tines (not shown) that may extend distally. Suchprotrusion or tines may be sized to engage the tendon. In this manner,upon the cradle portion 584 being moved to the second cradle position,the protrusion or tines extending directly from the second side of thecartridge may stabilize the tendon within the cradle portion.

Upon the physician being satisfied with the sandwiched position tendonportions, it may be preferable to move the locking element 594 back intothe locked position to stabilize the slider member 570. The physicianmay then anchor the repair device 500 to the lacerated tendon 5. Suchanchoring may be employed by actuating the trigger 558 such that thephysician may squeeze the trigger 558 toward the handle 556. Whileactuating the trigger 558, such movement may actuate and move the driveshaft 592 distally toward the cartridge 568. The drive shaft 592 mayinclude a distal shaft end 598 or pusher block that either contacts orindirectly contacts and moves the repair device 500 distally, out of thecartridge 568, so that the multiple anchors 504 extend through thetendon 5 and engage channels (not shown) defined in the bed surface 588of the cradle portion 584, as depicted in FIG. 42.

As depicted in FIGS. 37B and 42, the multiple anchors 504, upon beingdriven within channels of the cradle portion 584, move to thebefore-described curled portion 548 or curled configuration. Aspreviously set forth, the curled portions 548 of the multiple anchors504 may grab longitudinally extending bundles of the tendon 5. Further,the multiple anchors 504 hold the elongated flexible member 502 to anexterior surface of the tendon 5 so as to maintain ends of the laceratedtendon 5 abutted against each other. At this juncture, the lockingelement 594 may be moved to an unlocked position so that the slidermember 570 may be distally moved to the first cradle position. Therepair device 500 anchored to the lacerated tendon 5 may then be removedfrom the cradle portion 584. In this manner, the delivery device 552 maybe employed to anchor the repair device 500 to a lacerated tendon 5 sothat ends of the first and second tendon end portions of the laceratedtendon 5 may be fused together and undergo a proper healing process.

In one embodiment, it is contemplated that the slider member 570, alongwith its associated cradle portion 584, may be divided into two halves.For example, the slider member 570 may include a first slider portionand a second slider portion with respective first and second cradleportions (not shown), each being independently slideable and moveable.In this embodiment, the first and second slider members may also includeits own associated first and second locking elements and springs. Withthis arrangement, the physician may position a first tendon end portionin the first cradle portion and then slide the first cradle portionagainst the multiple anchors 504 of the first portion 522 of the repairdevice 500 to sandwich and hold the first tendon end portiontherebetween. Similarly, the second tendon end portion may then besandwiched between the cradle portion and the multiple anchors 504 ofthe second portion 524 of the repair device 500. In this manner, similarto the previous embodiment, the first and second ends of the laceratedtendon may be positioned to abut each other in the cradle portion andsandwiched with the multiple anchors 504 holding the tendon in positionso that the trigger 558 of the delivery device may be actuated to drivethe anchors 504 through the tendon and couple the repair device 500thereto.

In another embodiment, the slider member may be divided into two halves,similar to that discussed above, except one or both of the two halvesmay articulate or pivot away from each other. For example, the first andsecond slider members or cradle portions may pivot away from each other,such as in a v-configuration, to provide additional space for thephysician to position the first and second tendon portions in therespective first and second cradle portions.

In another embodiment, it is contemplated that the delivery device mayinclude a safety inter-lock. The safety inter-lock may include featuresthat prevent the physician from using a cartridge 568 and repair device500 that does not match the dimensions of the tendon.

In another embodiment, as depicted in FIG. 38, the elongated guide 560may rotate about its longitudinal axis 562 and relative to the body 554,as indicated by rotational arrow 591. Such rotation may facilitate thephysician to position the cradle portion 584 at a desired orientationand then rotate the body 554 and handle 556 to the orientation mostergonomic for the physician to perform the procedure. In anotherembodiment, the body 554 may articulate or rotate side-to-side (as shownby rotational arrow 593) or up and down (rotational arrow 595) relativeto the elongated guide 560 of the delivery device 552 such that the body554 may articulate or rotate in a direction transverse to thelongitudinal axis 562 of the elongated guide 560. In this manner, sucharticulation may ergonomically assist the physician as well asfacilitate the viewability of the cradle portion 584 for positioning thelacerated tendon.

Now with reference to FIGS. 43A and 43B, another embodiment of a repairdevice 600, similar to the previous embodiment, with anchors 604pre-inserted through and positioned within a flexible member 602, theanchors 604 being moveable from the first anchor position to the secondanchor position. The repair device 600 of this embodiment may beemployed in the same manner as described in the previous embodiment,except in this embodiment, the anchors 604 may be aligned along thelength of the flexible member 602. Further, in this embodiment, theupper portion 606 or base of the anchors 604 may be longer than theprevious embodiment such that the first and second legs 608, 610 of eachof the anchors 604 may be spaced with a greater width than the previousembodiment. Further, as depicted in FIG. 43A, the angled edge 612 of thefirst and second legs 608, 610 may be angled such that the point 614 ofeach of the first and second legs 608, 610 is at the end of an innersurface 616 of the legs. In other words, the angled edge 612 extendsdownward or distally from an outer surface 618 of each of the first andsecond legs 608, 610 to the inner surface 616 of each of the first andsecond legs 608, 610 of the anchors 604. With this arrangement, upon theanchors 604 being moved to the second anchor position as depicted inFIG. 43B, the angled edge 612 may facilitate the first and second legs608, 610 to move and curl toward each other in an inward manner.Further, the curled portion of each of the first and second legs 608,610 may be aligned along the length of the flexible member 602 withcurled portions of corresponding ones of the respective first and secondlegs 608, 610 of the anchors 604. In this manner, the flexible member622 may be positioned along an exterior surface of a severed tendon 5with the anchors 604 extending through the flexible member 602 and thetendon 5.

With reference to FIGS. 44A and 44B, another embodiment of a repairdevice 620, similar to the previous embodiments, having anchors 624pre-inserted through and positioned within a flexible member 622 andmoveable from the first anchor position to the second anchor position.Similar to the previous embodiment, the anchors 624 of this embodimentof the repair device 620 may be aligned in an anchor array along thelength of the flexible member 622. The repair device 620 of thisembodiment may include anchors 624 with an upper portion 626 or basehaving a shorter length than the upper portion 626 of previousembodiments. Further, the angled edge 628 extending to define a point630 may extend distally to the outer surface 632 of each of the firstand second legs 634, 636 such that, upon the anchors 624 being moved tothe second anchor position, the first and second legs 634, 636 of theanchors 624 may curl outward, as depicted in FIG. 43B. With thisarrangement, the flexible member 622 may be positioned along theexterior surface of a severed tendon 5 such that the flexible member 622may be fixed to the tendon with the anchors 624 extending through theflexible member 622 and the tendon 5.

In another embodiment, the anchors 604 of FIG. 43A and the anchors 624of FIG. 44A may be positioned along the length of a flexible member inan alternating arrangement. In other words, each anchor 604 of FIG. 43Amay be adjacent to one or more of the anchors 624 of FIG. 44A along thelength of the flexible member. Upon the anchors of this embodiment beingmoved to the second anchor position, the curled portions of the firstlegs of each anchor may be substantially aligned along the length of theflexible member. Similarly, the curled portions of the second legs maybe substantially aligned along the length of the flexible member.

Now with reference to FIGS. 45, 45A, and 45B, another embodiment and amore detailed view of a driving mechanism and the cartridge 568 of thedelivery device 552, previously set forth, is provided. With respect toFIG. 45, the delivery device 552 includes the elongated guide 560, thecartridge 568 positioned at the end of the elongated guide 560, and theslider member 570 (coupled to the cradle portion 584) moveable along theelongated guide 560, similar to that previously described. In oneembodiment, the cradle portion 584 may include multiple through holes640 extending through the cradle portion 584. For example, the throughholes 640 may extend through the bed surface 588 as well as the lateralsides 596 of the cradle portion 584. Such through holes 640 may assistthe physician in positioning and holding the severed tendons (not shown)within and along the bed surface 588 via pins or needles orneedle/suture arrangements (not shown) or the like. In this manner, thethrough holes 640 may assist the physician in maintaining the severedtendons positioned within the cradle portion 584 until the cradleportion 584 is moved proximally against the anchor points 544 (andcartridge, as previously described).

With respect to FIGS. 45A and 46, cross-sectional views of the cartridge568 and driving mechanism for the delivery device 552 are shown. Thedriving mechanism includes the drive shaft 592, pusher block 642, bladeblock 644, and an anchor guide 646. The before discussed cartridge 568may include both the blade block 644 and the anchor guide 646. The driveshaft 592 may be fixed to the pusher block 642 such that the drive shaft592 may move the pusher block 642 linearly upon actuating the handle 556(FIG. 45), such that the drive shaft 592 extends along and/or isco-axial with the axis 562 of the elongated guide 560 (FIG. 39). Thepusher block 642 may include a protrusion 648 that may align with anaperture 649 defined in the blade block 644 to ensure proper alignmentbetween the cartridge 568 and the pusher block 642.

As set forth, the cartridge 568 may include both the blade block 644 andthe anchor guide 646. The blade block 644 may include multiple blades650 extending distally therefrom. The blade block 644 may include afirst side 652, a second side 654 and one or more lateral sides 656. Thefirst side 652 may be opposite the second side 654 with one or morelateral sides 656 extending between the first and second sides 652, 654.The first side 652 may engage the pusher block 642 such that the pusherblock 642 may distally force or push the first side 652 of the bladeblock 644 forward within the anchor guide 646 and toward the cradleportion 584. Further, the one or more lateral sides 656 of the bladeblock 644 may be disposed at least partially within a hollow portion 658defined in the anchor guide 646 and at least partially within an endportion of the elongated guide 560. The multiple blades 650 may extendfrom the second side 654 of the blade block 644 such that the blades 650extend through the hollow portion 658 of the anchor guide 646 and intoslots 660 defined in the anchor guide 646.

With respect to FIGS. 46 and 47, the anchor guide 646 may include afirst end 662 and a second end 664, the second end 664 being the anchorengaging side of the cartridge 568 and the first end 662 defining thehollow portion 658 sized to receive the blade block 644. The anchorguide 646 may include an end portion extending distally from the hollowportion 658 to the second end 664. The end portion of the anchor guide646 may define slots 660 therein (for example, as depicted in the endview of the anchor guide in FIG. 47). The slots 660 may be sized andconfigured to each receive a corresponding blade 650 extending from theblade block 644. Further, the slots 660 may hold the anchors (not shown)so that each blade 650 may abut a top surface or upper portion of acorresponding anchor positioned in the slots 660. With this arrangement,as the pusher block 642 is moved forward, the blade block 644 moves froma first position to a second position, as depicted by arrow 668, in FIG.45A. In this manner, upon positioning a severed tendon within the cradleportion 584 and moving the cradle portion 584 toward the cartridge 568(as previously described relative to FIGS. 41 and 42), the trigger 558of the delivery device 552 may be actuated to, thereby, actuate thedrive shaft 592 and move the blade block 644 forward to the secondposition. As the blade block 644 moves to the second position, theblades 650 push the anchors through the slots 660 in the anchor guide646 and through the severed tendon to fix the flexible member (notshown) to an exterior surface of the severed tendon, as previouslydescribed.

Referring now to FIGS. 47 and 48, another embodiment of a flexiblemember 670 and anchors 672 sized and configured to be disposed withinthe anchor guide 646. In this embodiment, the anchor guide 646 mayinclude a channel 674 defined in the end portion of the anchor guide 646(best depicted in the end view of the anchor guide in FIG. 47). Thechannel 674 may include a longitudinal length (shown to extendhorizontally), extending between lateral sides 676 of the anchor guide646, and extending transverse or perpendicular relative to the length ofthe slots 660 (shown to extend vertically) holding the anchors. Further,the channel 674 may be defined in the anchor guide 646 so that each slot660 extends transverse and through the channel 674. In one embodiment,the channel 674 may be sized and configured to position the flexiblemember 670 therein such that the flexible member 670 is coupled adjacentto an upper portion 678 or base of each anchor 672.

As in previous embodiments, the anchors 672 may include the first andsecond legs 682, 684 and the upper portion 678 or base extending betweenthe first and second legs 682, 684 in a u-shaped configuration. Inaddition, the anchors 672 of this embodiment may include a tine 680 ormid-extension. The tine 680 may extend substantially parallel relativeto the first and second legs 682, 684. The tine 680 may be configured tomaintain the flexible member 670 adjacent (and below) the upper portion678 of the anchors 672 with, for example, canted tines 686 extendingfrom the tine 680. Further, as set forth, the flexible member 670 may besized to include a width less than the width of the anchors 672 so thatthe flexible member 670 is positionable within the channel 674 definedin the anchor guide 646. With this arrangement, the flexible member 670may be positioned within the cartridge 568 and adjacent the upperportion 678 of the anchors 672, rather than suspended adjacent theanchor points along the second side or end of the anchor guide, asdescribed in earlier embodiments.

Now with reference to FIG. 49, another embodiment of a medical devicesystem 700 having a medical device (not shown) and a delivery system 702is provided. In this embodiment, the delivery system 702 includes a body704, handle 706, and a trigger 708, each of which may be remote relativeto a cartridge 710, slider 712, and elongated guide 714. Further, inthis embodiment, the body 704 or trigger mechanism may include a cableor flexible housing 720 that may extend from the body 704. In oneembodiment, the flexible housing 720 may be fixed to the, for example,elongated guide 714. In another embodiment, the flexible housing 720 maybe removeably coupled to the elongated guide 714 (as indicated by arrow718) and/or the body 704 of the handle 706 such that, upon the severedtendon being positioned within the cradle 716, the physician may thensimply couple the flexible housing 720 and then actuate the trigger 708at a location remote from the elongated guide 714 to fix the repairdevice to the severed tendon. Further, in one embodiment, the cable orflexible housing may be operatively coupled to a proximal side of theelongated guide 714 so as to be operatively coupled to the proximal endof the drive shaft 592 (FIG. 45A). The flexible housing 720 may includea driving mechanism for moving the drive shaft and/or the pusher blockagainst the blade block to then push the anchors through the anchorguide and into the tendon, similar to that previously described. Asknown by one of ordinary skill in the art, such driving mechanism may beformed with a variety of driving mechanisms, such as with a cable,pulleys, a shaft, a coil, or any other suitable driving mechanism knownin the art.

With respect to FIGS. 49 and 50, one embodiment of a driving mechanismis provided. For example, the driving mechanism may include a cable 722operatively coupled to a drive shaft or pusher block 724. Further, thedriving mechanism may interact with an anchor guide 728 and one or moreblade blocks 726, the blade blocks 726 sized to slide within slots 730defined in the anchor guide 728. The cable 722 may extend between thetrigger 708 and the pusher block 724, the cable 722 extending through aportion of the elongated guide 714 and through the flexible housing 720.Further, the pusher block 724 may include an angled surface 732 (orradial surface) and may also include a flat surface 734, the angledsurface 732 extending to the flat surface 734 similar to a wedgeconfiguration. Further, the flat surface 734 may slide along and abutagainst a proximal 736 surface of the anchor guide 728.

Upon actuating the trigger 708, the cable 722 may be pulled (in tension)as indicated by arrow 738, transverse to axis 739, axis 739 extendingaxially through the elongated guide 714. The pusher block 724 may thenmove along the proximal surface 736 so that the angled surface 732 ofthe pusher block 724 pushes against the one or more blade blocks 726extending through the slots 730 of the anchor guide 728. As the pusherblock 724 continues to move in the direction of arrow 738, the angledsurface 732 of the pusher block 724 moves the blade blocks 726 downwardor a perpendicular direction relative to arrow 738, as indicated byarrow 740. In other words, the direction of movement of the pusher block724 may be transverse or substantially perpendicular to the direction ofmovement of the blade blocks 726. In this manner, the one or more bladeblocks 726 may move through the slots 730 such that blades 742 push theanchors 744 through the slots 730 and into the severed tendon positionedin the cradle portion (not shown) with the flexible member 745 fixedexternally to the severed tendon, similar to that described earlier.

In one embodiment, the one or more blade blocks 726 may include multipleblade blocks such that a single blade 742 corresponds with each bladeblock 726. In another embodiment, the one or more blade blocks 726 mayinclude multiple blade blocks such that each blade block correspondswith multiple blades 742. In another embodiment, there may be, forexample, two blade blocks 726, each blade block including multipleblades 742 corresponding with the number of anchors 744 for each side ofthe flexible member 745. In another embodiment, the one or more bladeblocks 726 may include a single blade block with multiple blades 742,each blade corresponding with a single anchor 744. In this manner, theanchors 744 may be anchored and fixed to the tendon in a simultaneousmanner or a consecutive/sequential manner.

While the above embodiment sets forth a wedge type configuration as thepusher block/cable arrangement to drive the one or more blade blocks726, other mechanisms may also be employed, such as multiple wedges tocorrespond with multiple blade blocks, a rocker configuration, awheel/cam arrangement, multiple lever arrangement, a rocker arrangement.Further, other embodiments may include spring-loaded plungers to forceone or more blade blocks into the anchor guide. In another embodiment,the driving mechanism may include a pneumatic device 746, a hydraulicdevice 748, and/or an electro-mechanical device 750 coupled to thedelivery system (see FIG. 49) for controlling actuation of the pusherblock and/or the blade blocks, as depicted in FIG. 49, which may beintegrated and employed as known to one of ordinary skill in the art.

In another embodiment, the flexible member 745 may be positioned andfixed to an opposite side of the tendon than that which has been setforth in some of the previous embodiments. Such may be employed, forexample, by positioning the flexible member 745 on the bed surface ofthe cradle portion 716 (rather than being held adjacent the points ofthe anchors 744), and then positioning the severed tendons over theflexible member 745. The anchors 744, extending slightly from thecartridge 729, may then pin the tendon between the distal side of thecartridge 729 and the bed surface of the cradle portion 716. Thedelivery system 702 may then be actuated, thereby, actuating the anchors744 through the tendon and then through the flexible member 745. In thismanner, the flexible member 745 may be positioned and fixed to theopposite side of the tendon, that is, the opposite side from which theanchors 744 first enter the tendon.

The various repair device embodiments disclosed herein may be applied toany one of various tendon and/or ligament repairs as well as tendonand/or ligament to bone repairs. For example, the various repair deviceembodiments may be employed for flexor tendon repairs, patellar tendonrepairs, Achilles tendon repairs, quadriceps tendon repairs, and/orbicep tendon repairs, or any other tendon, ligament, and tendon/ligamentto bone repairs.

While the invention may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the invention is not intended tobe limited to the particular forms disclosed. Rather, the inventionincludes employing any portion of one embodiment with anotherembodiment, all modifications, equivalents, and alternatives, fallingwithin the spirit and scope of the invention as defined by the followingappended claims.

What is claimed is:
 1. A medical device system configured to fuse afirst tendon end to a second tendon end of a lacerated tendon, themedical device system comprising: a delivery device including: a body; ahandle extending from the body; a trigger associated with the handle; anelongated guide operatively coupled to the body, the elongated guidedefining a longitudinal guide axis, the elongated guide including adrive shaft and a pusher block extending along the longitudinal guideaxis; a cartridge removably coupled to an end of the elongated guide;and a slider member slidably coupled to a distal portion of theelongated guide, the slider member including a cradle portion fixed tothe slider member and positioned distal of the slider member, the cradleportion including an elongated bed surface defining a longitudinalcradle axis, the longitudinal cradle axis being substantiallyperpendicular to the longitudinal guide axis, the bed surface of thecradle portion configured to receive a first tendon portion and a secondtendon portion of the lacerated tendon; and a repair device configuredto be positioned within the cartridge, the repair device including anelongated flexible member and anchors configured to extend through theelongated flexible member, each of the anchors including a base withlegs extending from the base from a proximal end to a distal free endsuch that the legs from the proximal end to the distal free end extendsubstantially parallel with the longitudinal guide axis and theelongated flexible member extends substantially perpendicular relativeto the longitudinal guide axis; wherein the anchors extend through theelongated flexible member along a first portion and a second portion ofthe elongated flexible member, the elongated flexible member includingan intermediate portion extending between the first portion and thesecond portion of the elongated flexible member; and wherein, upon thelacerated tendon being coupled to the elongated flexible member, thefirst and second portions of the elongated flexible member areconfigured to elongate as a force is placed upon the tendon and theintermediate portion of the elongated flexible member is configured tosubstantially resist elongation of the tendon.
 2. The medical devicesystem of claim 1, wherein, upon the lacerated tendon being positionedin the cradle portion, the trigger is actuated to compress the anchorsthrough the lacerated tendon to couple the elongated flexible member tothe lacerated tendon.
 3. The medical device system of claim 1, wherein,upon actuation of the trigger, the drive shaft moves distally to pushthe anchors through the cartridge so that the legs extend through thefirst and second tendon end portions, to then compress against the bedsurface so that the legs curl back into a distal side of the first andsecond tendon end portions with the base of each of the anchors couplingthe elongated flexible member to a proximal side of the first and secondtendon end portions.
 4. The medical device system of claim 1, whereinthe bed surface of the cradle portion comprises anvil channels definedtherein, the anvil channels sized and configured to receive end portionsof the legs of the anchors to curl the end portions and bundle portionsof the lacerated tendon.
 5. The medical device system of claim 1,wherein the elongated guide comprises a spring positioned within theelongated guide and coupled to the slider member, the spring configuredto bias the cradle portion toward the cartridge.
 6. The medical devicesystem of claim 1, further comprising a locking mechanism associatedwith the slider member, the locking mechanism configured to prevent theslider member from movement along the elongated guide.
 7. The medicaldevice system of claim 1, wherein the anchors comprise a u-shapedconfiguration.
 8. The medical device system of claim 1, wherein theelongated flexible member comprises a lattice structure.
 9. The medicaldevice system of claim 1, wherein the elongated flexible membercomprises one or more polymeric filaments.
 10. The medical device systemof claim 9, wherein the one or more polymeric filaments extend with atleast one of a weaved, braided, and knitted configuration.
 11. Themedical device system of claim 1, wherein the anchors are separate anddiscrete from each other, the anchors positioned along a length of theelongated flexible member in at least one of a staggered arrangement andan aligned arrangement.
 12. The medical device system of claim 1,further comprising a flexible cable configured to be operatively coupledbetween the handle and the elongated guide, the flexible cableconfigured to facilitate remote triggering of the handle relative to theelongated guide.
 13. The medical device system of claim 12, wherein theflexible cable is configured to operatively provide a force to thepusher block, the pusher block configured to push the anchors from thecartridge.
 14. The medical device system of claim 12, wherein theflexible cable is removably coupled to at least one of the elongatedguide and the handle.
 15. The medical device system of claim 1, furthercomprising a driving mechanism for driving the anchors from thecartridge, the driving mechanism comprising at least one of the driveshaft, a cable, a hydraulic mechanism, a pneumatic mechanism, and anelectro-mechanical mechanism.
 16. A medical device system configured tofuse a first tendon end to a second tendon end of a lacerated tendon,the medical device system comprising: a delivery device including: anelongated guide defining a longitudinal guide axis; a cartridgeremovably coupled to the elongated guide; and a moveable member coupledto the elongated guide and moveable relative to the elongated guide, themoveable member including a cradle portion, the cradle portion includingan elongated bed surface defining a longitudinal cradle axis, thelongitudinal cradle axis being substantially perpendicular to thelongitudinal guide axis, the bed surface of the cradle portionconfigured to receive a first tendon portion and a second tendon portionof the lacerated tendon; and a repair device configured to be positionedwithin the cartridge, the repair device including an elongated flexiblemember and anchors configured to extend through the elongated flexiblemember; wherein the anchors extend through the elongated flexible memberalong a first portion and a second portion of the elongated flexiblemember, the elongated flexible member including an intermediate portionextending between the first portion and the second portion of theelongated flexible member; and wherein, upon the lacerated tendon beingcoupled to the elongated flexible member, the first and second portionsof the elongated flexible member are configured to elongate as a forceis placed upon the tendon and the intermediate portion of the elongatedflexible member is configured to substantially resist elongation of thetendon.
 17. The medical device system of claim 16, wherein the anchorscomprise a u-shaped configuration.
 18. The medical device system ofclaim 16, wherein the elongated flexible member comprises a latticestructure.
 19. The medical device system of claim 16, wherein theelongated flexible member comprises one or more polymeric filaments. 20.The medical device system of claim 19, wherein the one or more polymericfilaments extend with at least one of a weaved, braided, and knittedconfiguration.
 21. The medical device system of claim 6, wherein theanchors are separate and discrete from each other, the anchorspositioned along a length of the elongated flexible member in at leastone of a staggered arrangement and an aligned arrangement.